Clinical chemistry device contract manufacturers
191 US facilities list clinical chemistry devices with FDA as a contract manufacturer (152) or contract sterilizer (44), across 167 FDA product codes in the Clinical chemistry classification panel.
FDA-registered (openFDA, export of Oct 21, 2026)
Most-listed clinical chemistry device types
| Product code | Device (FDA name) | Class | Facilities |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Class II | 26 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Class I | 22 |
| NBW | System, Test, Blood Glucose, Over The Counter | Class II | 21 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Class I | 20 |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class I | 20 |
| JIX | Calibrator, Multi-Analyte Mixture | Class II | 16 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Class I | 16 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | Class I | 16 |
| JIT | Calibrator, Secondary | Class II | 13 |
| PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) | Class II | 13 |
| QBJ | Integrated Continuous Glucose Monitoring System, Factory Calibrated | Class II | 12 |
| CGA | Glucose Oxidase, Glucose | Class II | 11 |
All 28 clinical chemistry product codes with at least 5 listed facilities
- QFG Alternate Controller Enabled Insulin Infusion Pump (10)
- JGS Electrode, Ion Specific, Sodium (9)
- JRL Unit, Filter, Membrane (9)
- CEM Electrode, Ion Specific, Potassium (8)
- CGZ Electrode, Ion-Specific, Chloride (8)
- GIM Tubes, Vacuum Sample, With Anticoagulant (8)
- JIN Nitroprusside, Ketones (Urinary, Non-Quant.) (8)
- LFR Glucose Dehydrogenase, Glucose (8)
- MDS Sensor, Glucose, Invasive (7)
- OOI Real Time Nucleic Acid Amplification System (7)
- CHH Enzymatic Esterase--Oxidase, Cholesterol (6)
- JHI Visual, Pregnancy Hcg, Prescription Use (6)
- JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) (5)
- NGE Test, Luteinizing Hormone (Lh), Over The Counter (5)
- QCD Continuous Glucose Monitor, Implanted, Adjunctive Use (5)
- SAF Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter (5)
Where they are
Top states by registered address.
| State | Facilities |
|---|---|
| California | 45 |
| Minnesota | 13 |
| Illinois | 12 |
| Texas | 12 |
| Massachusetts | 11 |
| Pennsylvania | 11 |
| North Carolina | 8 |
| Florida | 6 |
| Indiana | 6 |
| New York | 6 |
Device classes listed
Facilities listing at least one clinical chemistry device of each FDA class.
| Class | Facilities |
|---|---|
| Class I | 120 |
| Class II | 114 |
| Class III | 13 |
| Not classified | 1 |
All 191 facilities
| Company | FDA registration | Establishment type | Clinical chemistry devices listed | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| AALTO SCIENTIFIC LTD. | 3011325031 | Contract manufacturer | Single (Specified) Analyte Controls (Assayed And Unassayed); Multi-Analyte Controls, All Kinds (Assayed) | Eatonton, GA | Not verified | Oct 21, 2026 |
| ACON LABORATORIES, INC. | 2531491 | Contract manufacturer | Single (Specified) Analyte Controls (Assayed And Unassayed); System, Test, Blood Glucose, Over The Counter +1 more | San Diego, CA | Not verified | Oct 21, 2026 |
| ADVANCED ENGINEERING, INC. | 3010047203 | Contract manufacturer | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Huntington, IN | Not verified | Oct 21, 2026 |
| ADVANCED MOLDING TECHNOLOGIES | 3005743849 | Contract manufacturer | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Circle Pines, MN | Not verified | Oct 21, 2026 |
| ADVIN BIOTECH, INC. | 3010934853 | Contract manufacturer | Multi-Analyte Controls Unassayed | San Diego, CA | Not verified | Oct 21, 2026 |
| AERO-MED LLC | 3006191977 | Contract manufacturer | Blood Specimen Collection Convenience Kit (Excludes Hiv); Micro Pipette | East Hartford, CT | Not verified | Oct 21, 2026 |
| ALDEN MEDICAL LLC | 1221361 | Contract manufacturer | Calibrator, Secondary | W Springfield, MA | Not verified | Oct 21, 2026 |
| ALFA SCIENTIFIC DESIGNS, INC. | 2060833 | Contract manufacturer | Visual, Pregnancy Hcg, Prescription Use; Kit, Test, Pregnancy, Hcg, Over The Counter +3 more | Poway, CA | Not verified | Oct 21, 2026 |
| ALOM TECHNOLOGIES CORPORATION | 3004597845 | Contract manufacturer | Tubes, Vials, Systems, Serum Separators, Blood Collection; Dna Specimen Collection, Saliva +1 more | Fremont, CA | Not verified | Oct 21, 2026 |
| ALOM Technologies Corporation | 3015489159 | Contract manufacturer | System, Test, Blood Glucose, Over The Counter; Blood Specimen Collection Convenience Kit (Excludes Hiv) | Indianapolis, IN | Not verified | Oct 21, 2026 |
| ALURIS SCIENCES, LLC | 3049139337 | Contract manufacturer | Multi-Analyte Controls Unassayed | Carlsbad, CA | Not verified | Oct 21, 2026 |
| AQUAMEDIX | 3009893608 | Contract manufacturer | Unit, Filter, Membrane | Eden Prairie, MN | Not verified | Oct 21, 2026 |
| ARGONAUT MANUFACTURING SERVICES, INC. | 3013508066 | Contract manufacturer | Multi-Analyte Controls Unassayed; Reagents For Molecular Diagnostic Test Systems | Carlsbad, CA | Not verified | Oct 21, 2026 |
| AWARENESS TECHNOLOGY, INC. | 1036223 | Contract manufacturer | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Palm City, FL | Not verified | Oct 21, 2026 |
| Advanced Instruments, LLC | 1221020 | Contract manufacturer | Colorimeter, Photometer, Spectrophotometer For Clinical Use | Westbrook, ME | Not verified | Oct 21, 2026 |
| Alere San Diego, Inc. | 2020952 | Contract manufacturer | Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device | Pomona, CA | Not verified | Oct 21, 2026 |
| Alere San Diego, Inc. | 2027969 | Contract manufacturer | Enzymatic Method, Creatinine; Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica +1 more | San Diego, CA | Not verified | Oct 21, 2026 |
| Aprios Custom Mfg. | 3004612223 | Contract manufacturer | Unit, Filter, Membrane | Minneapolis, MN | Not verified | Oct 21, 2026 |
| Arthrex Logistic Center | 3009423112 | Contract manufacturer and sterilizer | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Balance, Analytical | Fort Myers, FL | Not verified | Oct 21, 2026 |
| Arthrex Manufacturing Inc. | 3015231789 | Contract manufacturer and sterilizer | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Balance, Analytical | Pendleton, SC | Not verified | Oct 21, 2026 |
| Arthrex, Inc. | 3010331645 | Contract manufacturer and sterilizer | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Ave Maria, FL | Not verified | Oct 21, 2026 |
| BAEBIES INC. | 3011240982 | Contract manufacturer | Alpha-L-Iduronidase (Idua) Newborn Screening Test System; Alpha-D-Glucosidase (Gaa) Newborn Screening Test System +2 more | Durham, NC | Not verified | Oct 21, 2026 |
| BCD AND ASSOCIATES | 1834174 | Contract manufacturer | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Indianapolis, IN | Not verified | Oct 21, 2026 |
| BECKMAN COULTER, INC. | 1061932 | Contract manufacturer | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Colorimeter, Photometer, Spectrophotometer For Clinical Use | Miami, FL | Not verified | Oct 21, 2026 |
| BECKMAN COULTER, INC. | 2050010 | Contract manufacturer | Single (Specified) Analyte Controls (Assayed And Unassayed); Calibrator, Multi-Analyte Mixture +50 more | Carlsbad, CA | Not verified | Oct 21, 2026 |
| BECKMAN COULTER, INC. | 2122870 | Contract manufacturer | Calibrator, Secondary; Nitroprusside, Ketones (Urinary, Non-Quant.) +12 more | Chaska, MN | Not verified | Oct 21, 2026 |
| BIO-RAD LABORATORIES, INC. | 3032705 | Contract manufacturer | Single (Specified) Analyte Controls (Assayed And Unassayed); Calibrator, Multi-Analyte Mixture +3 more | Woodinville, WA | Not verified | Oct 21, 2026 |
| BIODESIX, INC. | 3011854503 | Contract manufacturer | Blood Specimen Collection Convenience Kit (Excludes Hiv) | Louisville, CO | Not verified | Oct 21, 2026 |
| BIONOSTICS, INC. | 1220649 | Contract manufacturer | Single (Specified) Analyte Controls (Assayed And Unassayed); System, Test, Blood Glucose, Over The Counter +12 more | Devens, MA | Not verified | Oct 21, 2026 |
| BIORESOURCE TECHNOLOGY | 1058931 | Contract manufacturer | Multi-Analyte Controls, All Kinds (Assayed) | Weston, FL | Not verified | Oct 21, 2026 |
| Beckman Coulter, Inc | 3007448124 | Contract manufacturer | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Indianapolis, IN | Not verified | Oct 21, 2026 |
| Beckman Coulter, Inc. | 3008629785 | Contract manufacturer | Electrode, Ion Specific, Sodium | Hebron, KY | Not verified | Oct 21, 2026 |
| Bio-Rad Laboratories Inc. | 2016706 | Contract manufacturer | Calibrator, Multi-Analyte Mixture | Irvine, CA | Not verified | Oct 21, 2026 |
| Bio-Rad Laboratories Inc. | 3010127294 | Contract manufacturer | Calibrator, Multi-Analyte Mixture | Irvine, CA | Not verified | Oct 21, 2026 |
| Biochrom US | 3008382976 | Contract manufacturer | Analyzer, Chemistry, Micro, For Clinical Use | Holliston, MA | Not verified | Oct 21, 2026 |
| CARCLO TECHNICAL PLASTICS - Greensburg | 3021917553 | Contract manufacturer | Cuvette, Thermostated | Greensburg, PA | Not verified | Oct 21, 2026 |
| CATHTEK LLC | 3027553380 | Contract manufacturer | Tubes, Vials, Systems, Serum Separators, Blood Collection | Walkertown, NC | Not verified | Oct 21, 2026 |
| CHARTER MEDICAL, LLC | 1066733 | Contract manufacturer | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Winston Salem, NC | Not verified | Oct 21, 2026 |
| CHEMATICS, INC. | 1825396 | Contract manufacturer | Glucose Oxidase, Glucose; Enzymatic Esterase--Oxidase, Cholesterol | North Webster, IN | Not verified | Oct 21, 2026 |
| CLINIQA CORPORATION | 2085064 | Contract manufacturer | Single (Specified) Analyte Controls (Assayed And Unassayed); Calibrator, Multi-Analyte Mixture +10 more | San Marcos, CA | Not verified | Oct 21, 2026 |
| COGMEDIX | 3007712511 | Contract manufacturer | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | West Boylston, MA | Not verified | Oct 21, 2026 |
| CONDUCTIVE TECHNOLOGIES, INC. | 3004539335 | Contract manufacturer | System, Test, Blood Glucose, Over The Counter; Glucose Oxidase, Glucose | York, PA | Not verified | Oct 21, 2026 |
| CONE BIOPRODUCTS OF SEGUIN LLC | 3004152597 | Contract manufacturer | Single (Specified) Analyte Controls (Assayed And Unassayed); Multi-Analyte Controls, All Kinds (Assayed) | Seguin, TX | Not verified | Oct 21, 2026 |
| CORDICA MEDICAL, INC. | 1051594 | Contract manufacturer | Test, Luteinizing Hormone (Lh), Over The Counter; Kit, Test, Pregnancy, Hcg, Over The Counter | Morristown, TN | Not verified | Oct 21, 2026 |
| CREATIVE ESSENCES INC | 3006349554 | Contract manufacturer | Drink, Glucose Tolerance | Santa Fe Springs, CA | Not verified | Oct 21, 2026 |
| CURRIER PLASTICS | 1319436 | Contract manufacturer | Calibrator, Multi-Analyte Mixture; Analyzer, Chemistry (Photometric, Discrete), For Clinical Use +11 more | Auburn, NY | Not verified | Oct 21, 2026 |
| Carclo Technical Plastics - Export | 2530112 | Contract manufacturer | Micro Pipette | Export, PA | Not verified | Oct 21, 2026 |
| Carclo Technical Plastics - Latrobe | 3007135420 | Contract manufacturer | Tubes, Vials, Systems, Serum Separators, Blood Collection; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use +3 more | Latrobe, PA | Not verified | Oct 21, 2026 |
| Cardinal Health | 1915484 | Contract manufacturer | Tubes, Vials, Systems, Serum Separators, Blood Collection | Norfolk, NE | Not verified | Oct 21, 2026 |
| Classic Industries, Inc. | 2523553 | Contract manufacturer | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Latrobe, PA | Not verified | Oct 21, 2026 |
| Crosstex International | 1319130 | Contract manufacturer | Block, Heating | Rush, NY | Not verified | Oct 21, 2026 |
| Currie Medical, Inc. | 3013659199 | Contract manufacturer | Freezer | Franklin, TN | Not verified | Oct 21, 2026 |
| D&K Engineering | 3005268307 | Contract manufacturer | Station, Pipetting And Diluting, For Clinical Use | San Diego, CA | Not verified | Oct 21, 2026 |
| DEROYAL INDUSTRIES, INC. | 1055236 | Contract sterilizer | Tubes, Vials, Systems, Serum Separators, Blood Collection; Unit, Filter, Membrane +1 more | New Tazewell, TN | Not verified | Oct 21, 2026 |
| DIAMOND DIAGNOSTICS Inc | 3003030793 | Contract manufacturer | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Real Time Nucleic Acid Amplification System +4 more | Holliston, MA | Not verified | Oct 21, 2026 |
| DIASORIN INC. | 2182595 | Contract manufacturer | Single (Specified) Analyte Controls (Assayed And Unassayed); Calibrator, Multi-Analyte Mixture +3 more | Stillwater, MN | Not verified | Oct 21, 2026 |
| DISRUPTIVE MEDTECH, LLC | 3017486146 | Contract manufacturer | Blood Specimen Collection Convenience Kit (Excludes Hiv) | Laramie, WY | Not verified | Oct 21, 2026 |
| DRAKE PRECISION DENTAL LABORATORY, INC. | 3002706372 | Contract manufacturer | Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry | Charlotte, NC | Not verified | Oct 21, 2026 |
| DeRoyal Industries, Inc. | 1054241 | Contract sterilizer | Tubes, Vials, Systems, Serum Separators, Blood Collection; Unit, Filter, Membrane +1 more | New Tazewell, TN | Not verified | Oct 21, 2026 |
| E-BEAM SERVICES, INC. | 1531062 | Contract sterilizer | Tubes, Vials, Systems, Serum Separators, Blood Collection; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Lebanon, OH | Not verified | Oct 21, 2026 |
| E-BEAM SERVICES, INC. | 2245437 | Contract sterilizer | Tubes, Vials, Systems, Serum Separators, Blood Collection | Cranbury, NJ | Not verified | Oct 21, 2026 |
| EASTERN BUSINESS FORMS, LLC | 3008496607 | Contract manufacturer | Tubes, Vials, Systems, Serum Separators, Blood Collection | Greenville, SC | Not verified | Oct 21, 2026 |
| ELITechGroup Inc | 1717966 | Contract manufacturer | Calibrator, Multi-Analyte Mixture; Analyzer, Chemistry (Photometric, Discrete), For Clinical Use +9 more | Logan, UT | Not verified | Oct 21, 2026 |
| ENERCON TECHNOLOGIES | 3003018722 | Contract manufacturer | Real Time Nucleic Acid Amplification System | Gray, ME | Not verified | Oct 21, 2026 |
| East West Wisconsin | 3002736372 | Contract manufacturer | System, Test, Blood Glucose, Over The Counter; Glucose Oxidase, Glucose +3 more | Whitewater, WI | Not verified | Oct 21, 2026 |
| Eppendorf Manufacturing Corporation | 3005332796 | Contract manufacturer | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Enfield, CT | Not verified | Oct 21, 2026 |
| Fisher Diagnostics | 1181121 | Contract manufacturer | Single (Specified) Analyte Controls (Assayed And Unassayed); System, Test, Blood Glucose, Over The Counter +45 more | Middletown, VA | Not verified | Oct 21, 2026 |
| Flextronics America, LLC | 3006537560 | Contract manufacturer | System, Test, Blood Glucose, Over The Counter; Integrated Continuous Glucose Monitoring System, Factory Calibrated +1 more | Austin, TX | Not verified | Oct 21, 2026 |
| Flextronics International USA | 3011536730 | Contract manufacturer | System, Test, Blood Glucose, Over The Counter; Integrated Continuous Glucose Monitoring System, Factory Calibrated +3 more | Buffalo Grove, IL | Not verified | Oct 21, 2026 |
| Fujirebio Diagnostics, Inc. | 1643621 | Contract manufacturer | Calibrator, Secondary; Cyclosporine +1 more | Seguin, TX | Not verified | Oct 21, 2026 |
| Fujirebio Diagnostics, Inc. | 2521625 | Contract manufacturer | Single (Specified) Analyte Controls (Assayed And Unassayed); Calibrator, Secondary +4 more | Malvern, PA | Not verified | Oct 21, 2026 |
| GFS CHEMICALS, INC | 3008862790 | Contract manufacturer | Nephelometer, For Clinical Use | Powell, OH | Not verified | Oct 21, 2026 |
| GL DIABETES CORPORATION | 3009129531 | Contract manufacturer | Single (Specified) Analyte Controls (Assayed And Unassayed); System, Test, Blood Glucose, Over The Counter +2 more | San Diego, CA | Not verified | Oct 21, 2026 |
| Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | 1317188 | Contract manufacturer | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Buffalo, NY | Not verified | Oct 21, 2026 |
| HAMILTON CO. | 2915796 | Contract manufacturer | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Clinical Sample Concentrator +1 more | Reno, NV | Not verified | Oct 21, 2026 |
| HELMER Inc. | 3004973569 | Contract manufacturer | Freezer | Noblesville, IN | Not verified | Oct 21, 2026 |
| IMPILO - PHL Kubach | 3043025312 | Contract manufacturer | System, Test, Blood Glucose, Over The Counter | Philadelphia, PA | Not verified | Oct 21, 2026 |
| IMPILO, Inc. | 3022147580 | Contract manufacturer | System, Test, Blood Glucose, Over The Counter; Blood Specimen Collection Convenience Kit (Excludes Hiv) | Philadelphia, PA | Not verified | Oct 21, 2026 |
| IMS ENGINEERED PRODUCTS, LLC | 3009965750 | Contract manufacturer | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Des Plaines, IL | Not verified | Oct 21, 2026 |
| INTRICON CORPORATION | 2134850 | Contract manufacturer | Sensor, Glucose, Invasive; Automated Insulin Dosing , Threshold Suspend +1 more | Arden Hills, MN | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC | 1643817 | Contract sterilizer | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Blood Specimen Collection Convenience Kit (Excludes Hiv) | El Paso, TX | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC. | 1047843 | Contract sterilizer | Tubes, Vials, Systems, Serum Separators, Blood Collection | Spartanburg, SC | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC. | 1220477 | Contract sterilizer | Tubes, Vials, Systems, Serum Separators, Blood Collection; System, Test, Blood Glucose, Over The Counter +6 more | Northborough, MA | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC. | 1720929 | Contract sterilizer | Single (Specified) Analyte Controls (Assayed And Unassayed); Immunoassay For Detection Of Amniotic Fluid Protein(S). | Sandy, UT | Not verified | Oct 21, 2026 |
| IVD RESEARCH, LLC. | 2031468 | Contract manufacturer | Test, Luteinizing Hormone (Lh), Over The Counter; Immunoassay, Pregnanediol Glucuronide, Over The Counter | Carlsbad, CA | Not verified | Oct 21, 2026 |
| Impilo Phoenix | 3031789039 | Contract manufacturer | System, Test, Blood Glucose, Over The Counter; Blood Specimen Collection Convenience Kit (Excludes Hiv) | Phoenix, AZ | Not verified | Oct 21, 2026 |
| Innovize | 2135339 | Contract manufacturer | Continuous Glucose Monitor, Implanted, Adjunctive Use | North Oaks, MN | Not verified | Oct 21, 2026 |
| IntriCon Corporation Grey Fox | 3014498598 | Contract manufacturer | Sensor, Glucose, Invasive; Automated Insulin Dosing , Threshold Suspend +1 more | Arden Hills, MN | Not verified | Oct 21, 2026 |
| IntriCon Corporation VH | 3007939342 | Contract manufacturer | Sensor, Glucose, Invasive; Automated Insulin Dosing , Threshold Suspend | Vadnais Heights, MN | Not verified | Oct 21, 2026 |
| Isomedix Operations Inc | 3009888344 | Contract sterilizer | Blood Specimen Collection Convenience Kit (Excludes Hiv); Integrated Continuous Glucose Monitoring System, Factory Calibrated +1 more | El Paso, TX | Not verified | Oct 21, 2026 |
| Isomedix Operations Inc. | 2032112 | Contract sterilizer | Tubes, Vials, Systems, Serum Separators, Blood Collection; Azo Dye, Calcium | San Diego, CA | Not verified | Oct 21, 2026 |
| Isomedix Operations Inc. | 2246552 | Contract sterilizer | Alternate Controller Enabled Insulin Infusion Pump; Interoperable Automated Glycemic Controller | S Plainfield, NJ | Not verified | Oct 21, 2026 |
| Isomedix Operations Inc. | 3013820501 | Contract sterilizer | Integrated Continuous Glucose Monitoring System, Factory Calibrated | Chester, NY | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc | 2032098 | Contract sterilizer | Tubes, Vials, Systems, Serum Separators, Blood Collection; Single (Specified) Analyte Controls (Assayed And Unassayed) +7 more | Ontario, CA | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc. | 1424263 | Contract sterilizer | Tubes, Vials, Systems, Serum Separators, Blood Collection; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Libertyville, IL | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc. | 1450662 | Contract sterilizer | System, Test, Blood Glucose, Over The Counter; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use +1 more | Libertyville, IL | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc. | 2030624 | Contract sterilizer | Tubes, Vials, Systems, Serum Separators, Blood Collection; Alternate Controller Enabled Insulin Infusion Pump | Temecula, CA | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc. | 2183744 | Contract sterilizer | Continuous Glucose Monitor, Implanted, Adjunctive Use; Sensor, Glucose, Implanted, Non-Adjunctive Use +1 more | Minneapolis, MN | Not verified | Oct 21, 2026 |
| KATECHO LLC | 1930027 | Contract manufacturer | Bilirubin (Total And Unbound) In The Neonate Test System | Des Moines, IA | Not verified | Oct 21, 2026 |
| KENLOR INDUSTRIES, INC. | 2027370 | Contract manufacturer | Urinalysis Controls (Assayed And Unassayed) | Santa Ana, CA | Not verified | Oct 21, 2026 |
| LCR Hallcrest, LLC. (IL) | 1424489 | Contract manufacturer | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use; Regulator, Temperature | Glenview, IL | Not verified | Oct 21, 2026 |
| LOGIC PD, INC. | 3009046888 | Contract manufacturer | Colorimeter, Photometer, Spectrophotometer For Clinical Use | Eden Prairie, MN | Not verified | Oct 21, 2026 |
| Leica Biosystems Richmond, Inc. | 1419341 | Contract manufacturer | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Richmond, IL | Not verified | Oct 21, 2026 |
| Luminex Corporation | 1650733 | Contract manufacturer | Instrumentation For Clinical Multiplex Test Systems | Austin, TX | Not verified | Oct 21, 2026 |
| MAXIM BIOMEDICAL INC. | 1122236 | Contract manufacturer | Single (Specified) Analyte Controls (Assayed And Unassayed); Visual, Pregnancy Hcg, Prescription Use +1 more | Rockville, MD | Not verified | Oct 21, 2026 |
| MEDBIO, LLC. | 3009810261 | Contract manufacturer | Continuous Glucose Monitor, Implanted, Adjunctive Use; Sensor, Glucose, Implanted, Non-Adjunctive Use | Grand Rapids, MI | Not verified | Oct 21, 2026 |
| MEDICAL PRODUCTS LABORATORIES, INC. | 2513595 | Contract manufacturer | Drink, Glucose Tolerance | Philadelphia, PA | Not verified | Oct 21, 2026 |
| MERRIMACK MANUFACTURING | 3015192982 | Contract manufacturer | Alternate Controller Enabled Insulin Infusion Pump; Interoperable Automated Glycemic Controller | Manchester, NH | Not verified | Oct 21, 2026 |
| MGS GERMANTOWN A DIVISION OF MGS GROUP NA INC | 3011179004 | Contract manufacturer | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Germantown, WI | Not verified | Oct 21, 2026 |
| MIDWEST STERILIZATION CORP. | 1928237 | Contract sterilizer | Blood Specimen Collection Convenience Kit (Excludes Hiv); Tray, Blood Collection | Jackson, MO | Not verified | Oct 21, 2026 |
| MIDWEST STERILIZATION CORP. | 3005012805 | Contract sterilizer | Tray, Blood Collection | Laredo, TX | Not verified | Oct 21, 2026 |
| MIKA METAL FABRAICATING CO. | 3006104388 | Contract manufacturer | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Willoughby, OH | Not verified | Oct 21, 2026 |
| MINNETRONIX, INC. | 2133810 | Contract manufacturer | Continuous Glucose Monitor, Implanted, Adjunctive Use; Sensor, Glucose, Implanted, Non-Adjunctive Use | Saint Paul, MN | Not verified | Oct 21, 2026 |
| Merrimack Manufacturing | 3044561902 | Contract manufacturer | Alternate Controller Enabled Insulin Infusion Pump | Manchester, NH | Not verified | Oct 21, 2026 |
| Microgenics Corporation | 3010939897 | Contract manufacturer | Single (Specified) Analyte Controls (Assayed And Unassayed); Calibrator, Multi-Analyte Mixture +4 more | Fremont, CA | Not verified | Oct 21, 2026 |
| Millstone Medical Outsourcing LLC | 3010097171 | Contract manufacturer | Glucose Oxidase, Glucose; Calculator/Data Processing Module, For Clinical Use | Olive Branch, MS | Not verified | Oct 21, 2026 |
| NOVA BIOMEDICAL CORPORATION | 1219029 | Contract manufacturer | Single (Specified) Analyte Controls (Assayed And Unassayed); System, Test, Blood Glucose, Over The Counter +15 more | Waltham, MA | Not verified | Oct 21, 2026 |
| NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS | 3004193489 | Contract manufacturer | Single (Specified) Analyte Controls (Assayed And Unassayed); System, Test, Blood Glucose, Over The Counter +7 more | Billerica, MA | Not verified | Oct 21, 2026 |
| Nova Biomedical Corporation | 3011979858 | Contract manufacturer | Single (Specified) Analyte Controls (Assayed And Unassayed); System, Test, Blood Glucose, Over The Counter +6 more | Billerica, MA | Not verified | Oct 21, 2026 |
| Nypro Inc. (Chicago) | 1424235 | Contract manufacturer | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Gurnee, IL | Not verified | Oct 21, 2026 |
| ORASURE TECHNOLOGIES INC. | 3004142665 | Contract manufacturer | Dna Specimen Collection, Saliva | Bethlehem, PA | Not verified | Oct 21, 2026 |
| OSANG LLC | 3020885868 | Contract manufacturer | Single (Specified) Analyte Controls (Assayed And Unassayed); System, Test, Blood Glucose, Over The Counter +5 more | S Pasadena, CA | Not verified | Oct 21, 2026 |
| PARTER MEDICAL PRODUCTS, INC. | 2024311 | Contract sterilizer | Tubes, Vials, Systems, Serum Separators, Blood Collection; Oil Emulsion/Thymolphthalein (Titrimetric), Lipase | Carson, CA | Not verified | Oct 21, 2026 |
| PEAK 5 PACKAGING LLC | 3013652330 | Contract manufacturer | Tubes, Vials, Systems, Serum Separators, Blood Collection | Omaha, NE | Not verified | Oct 21, 2026 |
| PHAMATECH INC. | 2031229 | Contract manufacturer | Kit, Test, Pregnancy, Hcg, Over The Counter | San Diego, CA | Not verified | Oct 21, 2026 |
| PHOENIX MEDICAL PRODUCTS, INC. | 2320767 | Contract manufacturer | Balance, Analytical | Mountain City, TN | Not verified | Oct 21, 2026 |
| PLEXUS CORP. | 2183715 | Contract manufacturer | Instrumentation For Clinical Multiplex Test Systems | Neenah, WI | Not verified | Oct 21, 2026 |
| PLEXUS CORP. | 3004105270 | Contract manufacturer | Integrated Continuous Glucose Monitoring System, Factory Calibrated; Instrumentation For Clinical Multiplex Test Systems | Buffalo Grove, IL | Not verified | Oct 21, 2026 |
| PRO-TECH DESIGN & MFG., INC. | 2032521 | Contract manufacturer | Tubes, Vials, Systems, Serum Separators, Blood Collection; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Santa Fe Springs, CA | Not verified | Oct 21, 2026 |
| PRO-TECH Design & Mfg, Inc. | 3010531069 | Contract manufacturer | Tubes, Vials, Systems, Serum Separators, Blood Collection | Arlington, TX | Not verified | Oct 21, 2026 |
| PROMED PHARMA | 3003335547 | Contract manufacturer | Continuous Glucose Monitor, Implanted, Adjunctive Use; Sensor, Glucose, Implanted, Non-Adjunctive Use | Plymouth, MN | Not verified | Oct 21, 2026 |
| PROSPECT LIFE SCIENCES | 3014680149 | Contract manufacturer | Test For Esophageal Varices | Westminster, CO | Not verified | Oct 21, 2026 |
| Planet Innovation Products, Inc. | 2022994 | Contract manufacturer | Real Time Nucleic Acid Amplification System; Fluorometer, For Clinical Use | Irvine, CA | Not verified | Oct 21, 2026 |
| Primo Medical Group, Inc | 3009420598 | Contract manufacturer | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use; Regulator, Temperature | W Bridgewater, MA | Not verified | Oct 21, 2026 |
| Prince Sterilization Services, LLC | 3014498612 | Contract manufacturer and sterilizer | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Fairfield, NJ | Not verified | Oct 21, 2026 |
| Promega Corporation | 2134567 | Contract manufacturer | Clinical Sample Concentrator | Madison, WI | Not verified | Oct 21, 2026 |
| QUANTIMETRIX CORP. | 2020715 | Contract manufacturer | Single (Specified) Analyte Controls (Assayed And Unassayed); Urinalysis Controls (Assayed And Unassayed) | Redondo Beach, CA | Not verified | Oct 21, 2026 |
| REED CITY GROUP LIFE SCIENCES AND MEDICAL | 3027096471 | Contract manufacturer | Micro Mixer | Reed City, MI | Not verified | Oct 21, 2026 |
| RESEARCHDX,INC. | 3012177275 | Contract manufacturer | Investigational Use Only - Clinical Chemistry | Irvine, CA | Not verified | Oct 21, 2026 |
| ROBLING MEDICAL, LLC | 3007829657 | Contract manufacturer | Tubes, Vials, Systems, Serum Separators, Blood Collection | Youngsville, NC | Not verified | Oct 21, 2026 |
| RR DONNELLEY-SUPPLY CHAIN SOLUTIONS | 3006371704 | Contract manufacturer | Single (Specified) Analyte Controls (Assayed And Unassayed); System, Test, Blood Glucose, Over The Counter +11 more | Plover, WI | Not verified | Oct 21, 2026 |
| SA SCIENTIFIC, LTD | 1645225 | Contract manufacturer | Visual, Pregnancy Hcg, Prescription Use | San Antonio, TX | Not verified | Oct 21, 2026 |
| SCIENTIFIC MOLDING CORPORATION, LTD. DBA SMC LTD. | 3005910889 | Contract manufacturer | Tubes, Vials, Systems, Serum Separators, Blood Collection | Amery, WI | Not verified | Oct 21, 2026 |
| SHIMADZU U.S.A. MANUFACTURING, INC. | 3001040364 | Contract manufacturer | Mass Spectrometer, Clinical Use; Apparatus, High Pressure Liquid Chromatography | Canby, OR | Not verified | Oct 21, 2026 |
| SOLOMON PARK RESEARCH LABORATORIES, INC. | 3023437 | Contract manufacturer | Calibrator, Multi-Analyte Mixture | Burien, WA | Not verified | Oct 21, 2026 |
| SPECTRUM SOLUTIONS LLC | 3012758946 | Contract manufacturer | Blood Specimen Collection Convenience Kit (Excludes Hiv) | Draper, UT | Not verified | Oct 21, 2026 |
| STERI-TEK | 3012448339 | Contract sterilizer | Integrated Continuous Glucose Monitoring System, Factory Calibrated; Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management | Fremont, CA | Not verified | Oct 21, 2026 |
| STRECK LLC | 3017953151 | Contract manufacturer | Blood Collection Device For Cell-Free Nucleic Acid | La Vista, NE | Not verified | Oct 21, 2026 |
| SYNTRON BIORESEARCH, INC. | 2025760 | Contract manufacturer | Test, Luteinizing Hormone (Lh), Over The Counter; Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Carlsbad, CA | Not verified | Oct 21, 2026 |
| Sanmina | 3007867838 | Contract manufacturer | Real Time Nucleic Acid Amplification System | San Jose, CA | Not verified | Oct 21, 2026 |
| Sanmina Corporation | 3009609218 | Contract manufacturer | Real Time Nucleic Acid Amplification System | Carrollton, TX | Not verified | Oct 21, 2026 |
| Sekisui Diagnostics, LLC | 2030538 | Contract manufacturer | Visual, Pregnancy Hcg, Prescription Use | San Diego, CA | Not verified | Oct 21, 2026 |
| Spartronics Watertown LLC | 2133772 | Contract manufacturer | Single (Specified) Analyte Controls (Assayed And Unassayed); Osmolality Of Tears | Watertown, SD | Not verified | Oct 21, 2026 |
| Sterigenics Radiation Technologies, LLC | 2024024 | Contract sterilizer | Integrated Continuous Glucose Monitoring System, Factory Calibrated; Alternate Controller Enabled Insulin Infusion Pump +6 more | San Diego, CA | Not verified | Oct 21, 2026 |
| Sterigenics U.S. LLC | 1054811 | Contract sterilizer | Tubes, Vials, Systems, Serum Separators, Blood Collection; Unit, Filter, Membrane | Mulberry, FL | Not verified | Oct 21, 2026 |
| Sterigenics U.S. LLC | 2953359 | Contract sterilizer | System, Test, Blood Glucose, Over The Counter | Hayward, CA | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1036836 | Contract manufacturer and sterilizer | Tubes, Vials, Systems, Serum Separators, Blood Collection; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use +3 more | Haw River, NC | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1061124 | Contract sterilizer | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use +3 more | Charlotte, NC | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1319639 | Contract sterilizer | Tubes, Vials, Systems, Serum Separators, Blood Collection | Queensbury, NY | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1721676 | Contract sterilizer | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Unit, Filter, Membrane | Salt Lake City, UT | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 2022435 | Contract sterilizer | Alternate Controller Enabled Insulin Infusion Pump | Tustin, CA | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 2029015 | Contract sterilizer | Integrated Continuous Glucose Monitoring System, Factory Calibrated; Tubes, Vacuum Sample, With Anticoagulant +3 more | Ontario, CA | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 2029275 | Contract sterilizer | System, Test, Blood Glucose, Over The Counter; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use +3 more | Corona, CA | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 2219920 | Contract sterilizer | Capillary Blood Collection Device For Alternative Site Collection | Rockaway, NJ | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 1058584 | Contract sterilizer | Tubes, Vials, Systems, Serum Separators, Blood Collection; Tubes, Vacuum Sample, With Anticoagulant +3 more | Charlotte, NC | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 1423662 | Contract sterilizer | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Gurnee, IL | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 2011171 | Contract sterilizer | Tubes, Vacuum Sample, With Anticoagulant | Los Angeles, CA | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 3004111573 | Contract sterilizer | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use +7 more | Grand Prairie, TX | Not verified | Oct 21, 2026 |
| Sterigenics US, LLC | 1526534 | Contract sterilizer | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Lewis Center, OH | Not verified | Oct 21, 2026 |
| Synergy Health AST, LLC | 2030598 | Contract sterilizer | Integrated Continuous Glucose Monitoring System, Factory Calibrated; Alternate Controller Enabled Insulin Infusion Pump +2 more | San Diego, CA | Not verified | Oct 21, 2026 |
| Synergy Health AST, LLC | 3009882464 | Contract sterilizer | Sensor, Glucose, Invasive; Automated Insulin Dosing Device System, Single Hormonal Control +1 more | Saxonburg, PA | Not verified | Oct 21, 2026 |
| Sysmex America, Inc. | 3009495621 | Contract manufacturer | Calibrator, Multi-Analyte Mixture; Nitroprusside, Ketones (Urinary, Non-Quant.) +8 more | Buffalo Grove, IL | Not verified | Oct 21, 2026 |
| Sysmex America, Inc. - Vernon Hills | 3020704087 | Contract manufacturer | Calibrator, Multi-Analyte Mixture; Nitroprusside, Ketones (Urinary, Non-Quant.) +8 more | Vernon Hills, IL | Not verified | Oct 21, 2026 |
| TECAN CDMO SOLUTIONS MH, CORP. | 3003537036 | Contract manufacturer | Real Time Nucleic Acid Amplification System; Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis | Morgan Hill, CA | Not verified | Oct 21, 2026 |
| TECO DIAGNOSTICS | 1832216 | Contract manufacturer | Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Anaheim, CA | Not verified | Oct 21, 2026 |
| TESSY PLASTICS CORP. | 1317202 | Contract manufacturer | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Electrode, Ion Specific, Sodium +5 more | Elbridge, NY | Not verified | Oct 21, 2026 |
| THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 1523845 | Contract manufacturer | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use; Freezer | Marietta, OH | Not verified | Oct 21, 2026 |
| TN MICHIGAN, LLC | 3014717638 | Contract manufacturer | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Sault Sainte Marie, MI | Not verified | Oct 21, 2026 |
| TRUE DIAGNOSTICS, INC. | 3027500452 | Contract manufacturer | Test, Luteinizing Hormone (Lh), Over The Counter | Carlsbad, CA | Not verified | Oct 21, 2026 |
| Terumo BCT STERILIZATION SERVICES, Inc. | 1724474 | Contract sterilizer | Unit, Filter, Membrane | Lakewood, CO | Not verified | Oct 21, 2026 |
| The Dot Printer Inc. | 3011057574 | Contract manufacturer | Blood Specimen Collection Convenience Kit (Excludes Hiv) | Irvine, CA | Not verified | Oct 21, 2026 |
| ThermoGenesis Corp. | 2950374 | Contract manufacturer | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Rancho Cordova, CA | Not verified | Oct 21, 2026 |
| VERICHEM LABORATORIES, INC. | 1221645 | Contract manufacturer | Calibrator, Multi-Analyte Mixture; Calibrator, Secondary +1 more | Providence, RI | Not verified | Oct 21, 2026 |
| VWR CHEMICALS, LLC | 1550222 | Contract manufacturer | Real Time Nucleic Acid Amplification System; Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) +1 more | Solon, OH | Not verified | Oct 21, 2026 |
| Viant AS&O Holdings, LLC | 1218882 | Contract manufacturer | Photometric Method, Magnesium | Brimfield, MA | Not verified | Oct 21, 2026 |
| Viant San Antonio, Inc. | 3013404959 | Contract manufacturer | Balance, Analytical | San Antonio, TX | Not verified | Oct 21, 2026 |
| W.H.P.M., INC. | 2087033 | Contract manufacturer | Visual, Pregnancy Hcg, Prescription Use; Test, Luteinizing Hormone (Lh), Over The Counter +2 more | Irwindale, CA | Not verified | Oct 21, 2026 |
| WESTMED, INC. | 2028807 | Contract manufacturer | Tubes, Vials, Systems, Serum Separators, Blood Collection | Tucson, AZ | Not verified | Oct 21, 2026 |
| Westfall Technik Chicago | 3034707949 | Contract manufacturer | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Antioch, IL | Not verified | Oct 21, 2026 |
| ZEUS SCIENTIFIC LLC | 2242436 | Contract manufacturer | Column Chromatography & Color Development, Hydroxyproline | Branchburg, NJ | Not verified | Oct 21, 2026 |
| ZIEN MEDICAL TECHNOLOGIES LLC | 3009756153 | Contract manufacturer | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Salt Lake City, UT | Not verified | Oct 21, 2026 |