Microbiology device contract manufacturers
103 US facilities list microbiology devices with FDA as a contract manufacturer (83) or contract sterilizer (20), across 118 FDA product codes in the Microbiology classification panel.
FDA-registered (openFDA, export of Oct 21, 2026)
Most-listed microbiology device types
| Product code | Device (FDA name) | Class | Facilities |
|---|---|---|---|
| LIO | Device, Specimen Collection | Class I | 11 |
| JSM | Culture Media, Non-Propagating Transport | Class I | 9 |
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Class II | 6 |
| QBD | Microbial Nucleic Acid Storage And Stabilization Device | Class II | 6 |
| QKP | Coronavirus Antigen Detection Test System. | Not classified | 6 |
| LIB | Device, General Purpose, Microbiology, Diagnostic | Class I | 5 |
| LSL | Dna-Reagents, Neisseria | Class II | 5 |
| OID | Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing) | Class I | 5 |
| QKO | Reagent, Coronavirus Serological | Not classified | 5 |
Where they are
Top states by registered address.
| State | Facilities |
|---|---|
| California | 34 |
| Pennsylvania | 6 |
| Texas | 6 |
| Ohio | 5 |
| Illinois | 4 |
| Maryland | 4 |
| Utah | 4 |
| Minnesota | 3 |
| New York | 3 |
| Wisconsin | 3 |
Device classes listed
Facilities listing at least one microbiology device of each FDA class.
| Class | Facilities |
|---|---|
| Class I | 65 |
| Class II | 46 |
| Not classified | 16 |
| Class III | 1 |
All 103 facilities
| Company | FDA registration | Establishment type | Microbiology devices listed | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| AALTO SCIENTIFIC LTD. | 3011325031 | Contract manufacturer | Antigens, Cf (Including Cf Control), Adenovirus 1-33 | Eatonton, GA | Not verified | Oct 21, 2026 |
| ADVIN BIOTECH, INC. | 3010934853 | Contract manufacturer | Reagent, Coronavirus Serological | San Diego, CA | Not verified | Oct 21, 2026 |
| ALFA SCIENTIFIC DESIGNS, INC. | 2060833 | Contract manufacturer | Helicobacter Pylori | Poway, CA | Not verified | Oct 21, 2026 |
| ALLIED PRINTING SERVICES, INC. | 3007972833 | Contract manufacturer | Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing) | Manchester, CT | Not verified | Oct 21, 2026 |
| ARLINGTON SCIENTIFIC, INC. | 1641328 | Contract manufacturer | Antisera, Control For Nontreponemal Tests; Kit, Screening, Staphylococcus Aureus +1 more | Springville, UT | Not verified | Oct 21, 2026 |
| AUER 2260 | 3020440077 | Contract manufacturer | Device, General Purpose, Microbiology, Diagnostic | Mesa, AZ | Not verified | Oct 21, 2026 |
| AUER PRECISION | 2030652 | Contract manufacturer | Susceptibility Test Discs, Antimicrobial; Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing | Mesa, AZ | Not verified | Oct 21, 2026 |
| AZER SCIENTIFIC, INC. | 3009963993 | Contract manufacturer | Coronavirus Antigen Detection Test System. | Morgantown, PA | Not verified | Oct 21, 2026 |
| Airgas Therapeutics LLC | 2518435 | Contract manufacturer | Device, Gas Generating | Plumsteadville, PA | Not verified | Oct 21, 2026 |
| BECKMAN COULTER, INC. | 1061932 | Contract manufacturer | Device, Microtiter Diluting/Dispensing; Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | Miami, FL | Not verified | Oct 21, 2026 |
| BECKMAN COULTER, INC. | 2050010 | Contract manufacturer | Antistreptolysin - Titer/Streptolysin O Reagent; Antideoxyribonuclease, Streptococcus Spp. | Carlsbad, CA | Not verified | Oct 21, 2026 |
| BECTON, DICKINSON & CO., (BD) | 1024879 | Contract sterilizer | Monitor, Microbial Growth | Sumter, SC | Not verified | Oct 21, 2026 |
| BENCHMARK ELECTRONICS, INC. | 2133641 | Contract manufacturer | Bath, Incubators/Water, All | Winona, MN | Not verified | Oct 21, 2026 |
| BIO SB, INC. | 3008773547 | Contract manufacturer | Quality Control Slides | Santa Barbara, CA | Not verified | Oct 21, 2026 |
| BIO-RAD LABORATORIES, INC. | 3032705 | Contract manufacturer | Reagent, Borrelia Serological Reagent; Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii +15 more | Woodinville, WA | Not verified | Oct 21, 2026 |
| BIO-TEST MEDICAL, INC. | 2518630 | Contract manufacturer | Kit, Quality Control For Culture Media | Gibsonia, PA | Not verified | Oct 21, 2026 |
| BIOMERIEUX, INC. | 1450405 | Contract manufacturer | Culture Media, Non-Selective And Non-Differential | Lombard, IL | Not verified | Oct 21, 2026 |
| BIOMERIEUX, INC. | 1950204 | Contract manufacturer | Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates | Hazelwood, MO | Not verified | Oct 21, 2026 |
| BION ENTERPRISES, LTD. | 1419968 | Contract manufacturer | Reagent, Borrelia Serological Reagent; Quality Control Slides +9 more | Des Plaines, IL | Not verified | Oct 21, 2026 |
| BREATHH INC | 3017171515 | Contract manufacturer | Coronavirus Antigen Detection Test System. | San Diego, CA | Not verified | Oct 21, 2026 |
| Baxter Healthcare of Puerto Rico LLC | 2649614 | Contract sterilizer | System, Transport, Aerobic; Transport Systems, Anaerobic | Aibonito, PR | Not verified | Oct 21, 2026 |
| Beckman Coulter, Inc. | 2919016 | Contract manufacturer | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation; Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples | West Sacramento, CA | Not verified | Oct 21, 2026 |
| BioFire Defense, LLC | 3010770794 | Contract manufacturer | Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness | Salt Lake City, UT | Not verified | Oct 21, 2026 |
| CALBIOTECH, INC. | 2090110 | Contract manufacturer | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii; Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus +4 more | El Cajon, CA | Not verified | Oct 21, 2026 |
| COMAR LLC | 3010423292 | Contract manufacturer | Deformability Cytometry For Sepsis Risk Assessment | Woodville, WI | Not verified | Oct 21, 2026 |
| COPAN DIAGNOSTICS, INC. | 2436875 | Contract manufacturer | Device, Specimen Collection; Culture Media, Non-Propagating Transport +4 more | Murrieta, CA | Not verified | Oct 21, 2026 |
| COPAN Diagnostics, Inc. | 3017063217 | Contract manufacturer | Device, Specimen Collection; Culture Media, Non-Propagating Transport | Carlsbad, CA | Not verified | Oct 21, 2026 |
| Carclo Technical Plastics - Latrobe | 3007135420 | Contract manufacturer | Device, General Purpose, Microbiology, Diagnostic | Latrobe, PA | Not verified | Oct 21, 2026 |
| Cardinal Health | 1915484 | Contract manufacturer | Device, Specimen Collection | Norfolk, NE | Not verified | Oct 21, 2026 |
| Copan Industries, Inc. | 3015441043 | Contract manufacturer | Device, Specimen Collection; Culture Media, Non-Propagating Transport +2 more | Aguadilla, PR | Not verified | Oct 21, 2026 |
| DEROYAL INDUSTRIES, INC. | 1055236 | Contract sterilizer | Device, Specimen Collection; Culture Media, Non-Selective And Non-Differential | New Tazewell, TN | Not verified | Oct 21, 2026 |
| DIAMOND DIAGNOSTICS Inc | 3003030793 | Contract manufacturer | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation; Reagent, Borrelia Serological Reagent +12 more | Holliston, MA | Not verified | Oct 21, 2026 |
| DIASORIN INC. | 2182595 | Contract manufacturer | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis | Stillwater, MN | Not verified | Oct 21, 2026 |
| DeRoyal Industries, Inc. | 1054241 | Contract sterilizer | Device, Specimen Collection; Culture Media, Non-Selective And Non-Differential | New Tazewell, TN | Not verified | Oct 21, 2026 |
| EKF Life Sciences | 3017101757 | Contract manufacturer | Microbial Nucleic Acid Storage And Stabilization Device | South Bend, IN | Not verified | Oct 21, 2026 |
| ENERCON TECHNOLOGIES | 3003018722 | Contract manufacturer | Respiratory Virus Panel Nucleic Acid Assay System; Influenza A And Influenza B Multiplex Nucleic Acid Assay +1 more | Gray, ME | Not verified | Oct 21, 2026 |
| ESI MANUFACTURING, LLC | 3013490757 | Contract manufacturer | Discs, Strips And Reagents, Microorganism Differentiation | Gleason, WI | Not verified | Oct 21, 2026 |
| EVCO PLASTICS, DIV. DON EVANS, INC. | 2124274 | Contract manufacturer | System, Blood Culturing | Deforest, WI | Not verified | Oct 21, 2026 |
| Ethos Biosciences, INC. | 2247035 | Contract manufacturer | Discs, Strips And Reagents, Microorganism Differentiation; Kit, Identification, Mycobacteria | Logan Township, NJ | Not verified | Oct 21, 2026 |
| Fisher Diagnostics | 1181121 | Contract manufacturer | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | Middletown, VA | Not verified | Oct 21, 2026 |
| Fujirebio Diagnostics, Inc. | 2521625 | Contract manufacturer | Reagent, Coronavirus Serological | Malvern, PA | Not verified | Oct 21, 2026 |
| Grifols Diagnostic Solutions Inc. | 2032600 | Contract manufacturer | Test, Hiv Detection; Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus +1 more | San Diego, CA | Not verified | Oct 21, 2026 |
| HACH COMPANY | 1833407 | Contract manufacturer | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Ames, IA | Not verified | Oct 21, 2026 |
| HAMILTON CO. | 2915796 | Contract manufacturer | Device, Microtiter Diluting/Dispensing | Reno, NV | Not verified | Oct 21, 2026 |
| HARDY DIAGNOSTICS | 2022807 | Contract manufacturer | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation; Monitor, Microbial Growth +1 more | Orcutt, CA | Not verified | Oct 21, 2026 |
| Hardy Diagnostics | 3009547954 | Contract manufacturer | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | Springboro, OH | Not verified | Oct 21, 2026 |
| IMMCO DIAGNOSTICS, INC. | 3015376545 | Contract manufacturer | Culture Media, Non-Propagating Transport | Williamsville, NY | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC | 1643817 | Contract sterilizer | Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing) | El Paso, TX | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC. | 1047843 | Contract sterilizer | Monitor, Microbial Growth | Spartanburg, SC | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC. | 1220477 | Contract sterilizer | Device, Specimen Collection; Culture Media, Non-Propagating Transport +3 more | Northborough, MA | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC. | 1720929 | Contract sterilizer | Culture Media, Non-Propagating Transport | Sandy, UT | Not verified | Oct 21, 2026 |
| IVD RESEARCH, LLC. | 2031468 | Contract manufacturer | Reagents, 2019-Novel Coronavirus Nucleic Acid | Carlsbad, CA | Not verified | Oct 21, 2026 |
| Isomedix Operations Inc | 3009888344 | Contract sterilizer | Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing) | El Paso, TX | Not verified | Oct 21, 2026 |
| Isomedix Operations Inc. | 2032112 | Contract sterilizer | Susceptibility Test Discs, Antimicrobial | San Diego, CA | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc. | 2183744 | Contract sterilizer | Device, Specimen Collection; Culture Media, Non-Propagating Transport | Minneapolis, MN | Not verified | Oct 21, 2026 |
| JAMES ALEXANDER CORP. | 2242239 | Contract manufacturer | Discs, Strips And Reagents, Microorganism Differentiation; Device, Gas Generating | Blairstown, NJ | Not verified | Oct 21, 2026 |
| KENLOR INDUSTRIES, INC. | 2027370 | Contract manufacturer | Helicobacter Pylori | Santa Ana, CA | Not verified | Oct 21, 2026 |
| LEGACY BIOLOGICALS | 3015715780 | Contract manufacturer | Culture Media, Antibiotic Assay | Baltimore, MD | Not verified | Oct 21, 2026 |
| LIFE TECHNOLOGIES CORPORATION | 3009207631 | Contract manufacturer | Reagents, 2019-Novel Coronavirus Nucleic Acid | Austin, TX | Not verified | Oct 21, 2026 |
| LONZA WALKERSVILLE, INC. | 1114298 | Contract manufacturer | Culture Media, Selective Broth; Supplement, Culture Media | Walkersville, MD | Not verified | Oct 21, 2026 |
| LUMIQUICK DIAGNOSTICS, INC. | 3005984081 | Contract manufacturer | Reagent, Coronavirus Serological; Helicobacter Pylori | Santa Clara, CA | Not verified | Oct 21, 2026 |
| Life Technologies Corporation | 3003335080 | Contract manufacturer | Reagents, 2019-Novel Coronavirus Nucleic Acid | Frederick, MD | Not verified | Oct 21, 2026 |
| MAXIM BIOMEDICAL INC. | 1122236 | Contract manufacturer | Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users | Rockville, MD | Not verified | Oct 21, 2026 |
| MERIDIAN BIOSCIENCE, INC. | 1524213 | Contract manufacturer | Antisera, All Types, Escherichia Coli | Cincinnati, OH | Not verified | Oct 21, 2026 |
| MIDWEST STERILIZATION CORP. | 1928237 | Contract sterilizer | Enzyme Linked Immunoabsorbent Assay, Rubella | Jackson, MO | Not verified | Oct 21, 2026 |
| MML DIAGNOSTICS PACKAGING, INC. | 3018348 | Contract manufacturer | Device, Specimen Collection; Culture Media, Non-Propagating Transport +1 more | Troutdale, OR | Not verified | Oct 21, 2026 |
| NEW LIFE DIAGNOSTICS INC. | 3011527950 | Contract manufacturer | Antigen, Fluorescent Antibody Test, Schistosoma Mansoni; Antigen, Agglutinating, Echinococcus Spp. +5 more | Carlsbad, CA | Not verified | Oct 21, 2026 |
| Nalge Nunc International Corporation | 1314344 | Contract manufacturer | Device, Gas Generating | Rochester, NY | Not verified | Oct 21, 2026 |
| ORASURE TECHNOLOGIES INC. | 3004142665 | Contract manufacturer | Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples; Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay | Bethlehem, PA | Not verified | Oct 21, 2026 |
| PAIDEX INC. | 3031001098 | Contract manufacturer | Microbial Nucleic Acid Storage And Stabilization Device | Pensacola, FL | Not verified | Oct 21, 2026 |
| PARTER STERILIZATION SERVICES | 3005735987 | Contract sterilizer | Device, General Purpose, Microbiology, Diagnostic | Ontario, CA | Not verified | Oct 21, 2026 |
| PHAMATECH INC. | 2031229 | Contract manufacturer | Reagent, Coronavirus Serological | San Diego, CA | Not verified | Oct 21, 2026 |
| PLASTIKON HEALTHCARE | 3009840089 | Contract manufacturer | Reagent/Device, Inoculum Calibration | Lawrence, KS | Not verified | Oct 21, 2026 |
| PRO-TECH DESIGN & MFG., INC. | 2032521 | Contract manufacturer | Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay | Santa Fe Springs, CA | Not verified | Oct 21, 2026 |
| PURITAN MEDICAL PRODUCTS COMPANY LLC | 1216735 | Contract manufacturer | Device, Specimen Collection; System, Transport, Aerobic +1 more | Guilford, ME | Not verified | Oct 21, 2026 |
| Planet Innovation Products, Inc. | 2022994 | Contract manufacturer | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus; C. Difficile Nucleic Acid Amplification Test Assay +1 more | Irvine, CA | Not verified | Oct 21, 2026 |
| Plastikon Industries | 3009974297 | Contract manufacturer | Device, General Purpose, Microbiology, Diagnostic; Device, Microtiter Diluting/Dispensing | Hayward, CA | Not verified | Oct 21, 2026 |
| QUALITY BIORESOURCES, INC | 1645368 | Contract manufacturer | Culture Media, Selective And Non-Differential | Seguin, TX | Not verified | Oct 21, 2026 |
| RPI BIOSOLUTIONS | 3025663244 | Contract manufacturer | Microbial Nucleic Acid Storage And Stabilization Device; Dna-Reagents, Neisseria +8 more | Mundelein, IL | Not verified | Oct 21, 2026 |
| SCANTIBODIES LABORATORY INC. | 3026664926 | Contract manufacturer | Coronavirus Antigen Detection Test System.; Reagent, Coronavirus Serological +5 more | San Diego, CA | Not verified | Oct 21, 2026 |
| SCANTIBODIES LABORATORY, INC. | 2020808 | Contract manufacturer | Coronavirus Antigen Detection Test System.; Reagent, Borrelia Serological Reagent +2 more | Santee, CA | Not verified | Oct 21, 2026 |
| SCYTEK LABORATORIES, INC. | 3004074729 | Contract manufacturer | Quality Control Slides | Logan, UT | Not verified | Oct 21, 2026 |
| SIO2 MEDICAL PRODUCTS, LLC | 3013046485 | Contract manufacturer | Microbial Nucleic Acid Storage And Stabilization Device | Auburn, AL | Not verified | Oct 21, 2026 |
| STANBIO LABORATORY | 1616487 | Contract manufacturer | Microbial Nucleic Acid Storage And Stabilization Device | Boerne, TX | Not verified | Oct 21, 2026 |
| Sekisui Diagnostics, LLC | 2030538 | Contract manufacturer | Antigens, All Groups, Streptococcus Spp.; Devices Detecting Influenza A, B, And C Virus Antigens +1 more | San Diego, CA | Not verified | Oct 21, 2026 |
| Springboard Manufacturing | 3021140368 | Contract manufacturer | Respiratory Virus Panel Nucleic Acid Assay System; Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents +1 more | Rancho Cordova, CA | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1061124 | Contract sterilizer | Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing) | Charlotte, NC | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1319639 | Contract sterilizer | Culture Media, Non-Propagating Transport | Queensbury, NY | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 2022435 | Contract sterilizer | Kit, Screening, Urine | Tustin, CA | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 2029275 | Contract sterilizer | Device, Specimen Collection; Device, General Purpose, Microbiology, Diagnostic +3 more | Corona, CA | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 1423662 | Contract sterilizer | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation; System, Blood Culturing | Gurnee, IL | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 3004111573 | Contract sterilizer | Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing); Susceptibility Test Discs, Antimicrobial | Grand Prairie, TX | Not verified | Oct 21, 2026 |
| Sterigenics US, LLC | 1526534 | Contract sterilizer | System, Detection, Bacterial, For Platelet Transfusion Products | Lewis Center, OH | Not verified | Oct 21, 2026 |
| TECAN CDMO SOLUTIONS MH, CORP. | 3003537036 | Contract manufacturer | Deformability Cytometry For Sepsis Risk Assessment | Morgan Hill, CA | Not verified | Oct 21, 2026 |
| THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 1523845 | Contract manufacturer | Bath, Incubators/Water, All | Marietta, OH | Not verified | Oct 21, 2026 |
| TRUE DIAGNOSTICS, INC. | 3027500452 | Contract manufacturer | Coronavirus Antigen Detection Test System. | Carlsbad, CA | Not verified | Oct 21, 2026 |
| The Dot Printer Inc. | 3011057574 | Contract manufacturer | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents; Reagents, Non-Variola Orthopoxvirus Nucleic Acid. | Irvine, CA | Not verified | Oct 21, 2026 |
| VORZEIGEN | 3007344102 | Contract manufacturer | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Connersville, IN | Not verified | Oct 21, 2026 |
| VWR CHEMICALS, LLC | 1550222 | Contract manufacturer | Dna-Reagents, Neisseria; System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | Solon, OH | Not verified | Oct 21, 2026 |
| Westec Plastics Corporation | 3005288662 | Contract manufacturer | Deformability Cytometry For Sepsis Risk Assessment | Livermore, CA | Not verified | Oct 21, 2026 |
| Wondfo USA Co., Ltd. | 3016252795 | Contract manufacturer | Antigens, All Groups, Streptococcus Spp. | San Diego, CA | Not verified | Oct 21, 2026 |
| XCALIBER SCIENCES, INC. | 3017467459 | Contract manufacturer | Quality Control Material, Genetics, Dna | San Diego, CA | Not verified | Oct 21, 2026 |
| iHealth Manufacturing Inc | 3023947183 | Contract manufacturer | Coronavirus Antigen Detection Test System.; Covid-19 Multi-Analyte Antigen Device +1 more | Irwindale, CA | Not verified | Oct 21, 2026 |