Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) contract manufacturers
22 US facilities list FDA product code JJX as a contract manufacturer (20) or contract sterilizer (2).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Single (Specified) Analyte Controls (Assayed And Unassayed)
- Product code
- JJX (FDA product classification database)
- Device class
- Class I
- Regulation
- 21 CFR 862.1660
- Classification panel
- Clinical chemistry
Where they are
California 8 · Massachusetts 4 · Georgia 1 · Maryland 1 · Minnesota 1 · Pennsylvania 1 · South Dakota 1 · Texas 1 · Utah 1 · Virginia 1 · Washington 1 · Wisconsin 1
All 22 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| AALTO SCIENTIFIC LTD. | 3011325031 | Contract manufacturer | Clinical chemistry; Hematology; Microbiology | Eatonton, GA | Not verified | Oct 21, 2026 |
| ACON LABORATORIES, INC. | 2531491 | Contract manufacturer | Clinical chemistry | San Diego, CA | Not verified | Oct 21, 2026 |
| BECKMAN COULTER, INC. | 2050010 | Contract manufacturer | Clinical chemistry; Clinical toxicology; Immunology +3 more | Carlsbad, CA | Not verified | Oct 21, 2026 |
| BIO-RAD LABORATORIES, INC. | 3032705 | Contract manufacturer | Microbiology; Immunology; Clinical chemistry | Woodinville, WA | Not verified | Oct 21, 2026 |
| BIONOSTICS, INC. | 1220649 | Contract manufacturer | Clinical chemistry; Hematology; Clinical toxicology | Devens, MA | Not verified | Oct 21, 2026 |
| CLINIQA CORPORATION | 2085064 | Contract manufacturer | Clinical chemistry; Hematology; Immunology | San Marcos, CA | Not verified | Oct 21, 2026 |
| CONE BIOPRODUCTS OF SEGUIN LLC | 3004152597 | Contract manufacturer | Clinical chemistry | Seguin, TX | Not verified | Oct 21, 2026 |
| DIASORIN INC. | 2182595 | Contract manufacturer | Clinical chemistry; Immunology; Microbiology | Stillwater, MN | Not verified | Oct 21, 2026 |
| Fisher Diagnostics | 1181121 | Contract manufacturer | Clinical chemistry; Immunology; Hematology +4 more | Middletown, VA | Not verified | Oct 21, 2026 |
| Fujirebio Diagnostics, Inc. | 2521625 | Contract manufacturer | Clinical chemistry; Immunology; Clinical toxicology +2 more | Malvern, PA | Not verified | Oct 21, 2026 |
| GL DIABETES CORPORATION | 3009129531 | Contract manufacturer | Clinical chemistry | San Diego, CA | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC. | 1720929 | Contract sterilizer | Orthopedic; General and plastic surgery; Cardiovascular +11 more | Sandy, UT | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc | 2032098 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +12 more | Ontario, CA | Not verified | Oct 21, 2026 |
| MAXIM BIOMEDICAL INC. | 1122236 | Contract manufacturer | Clinical chemistry; Microbiology | Rockville, MD | Not verified | Oct 21, 2026 |
| Microgenics Corporation | 3010939897 | Contract manufacturer | Clinical toxicology; Clinical chemistry; Hematology +1 more | Fremont, CA | Not verified | Oct 21, 2026 |
| NOVA BIOMEDICAL CORPORATION | 1219029 | Contract manufacturer | Clinical chemistry; Hematology | Waltham, MA | Not verified | Oct 21, 2026 |
| Nova Biomedical Corporation | 3011979858 | Contract manufacturer | Clinical chemistry | Billerica, MA | Not verified | Oct 21, 2026 |
| NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS | 3004193489 | Contract manufacturer | Clinical chemistry | Billerica, MA | Not verified | Oct 21, 2026 |
| OSANG LLC | 3020885868 | Contract manufacturer | Clinical chemistry | S Pasadena, CA | Not verified | Oct 21, 2026 |
| QUANTIMETRIX CORP. | 2020715 | Contract manufacturer | Clinical chemistry; Hematology | Redondo Beach, CA | Not verified | Oct 21, 2026 |
| RR DONNELLEY-SUPPLY CHAIN SOLUTIONS | 3006371704 | Contract manufacturer | Clinical chemistry; Cardiovascular; Anesthesiology | Plover, WI | Not verified | Oct 21, 2026 |
| Spartronics Watertown LLC | 2133772 | Contract manufacturer | Neurology; Radiology; Clinical chemistry +8 more | Watertown, SD | Not verified | Oct 21, 2026 |
Related clinical chemistry product codes
- JKA Tubes, Vials, Systems, Serum Separators, Blood Collection (26)
- NBW System, Test, Blood Glucose, Over The Counter (21)
- JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use (20)
- LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use (20)
- JIX Calibrator, Multi-Analyte Mixture (16)
- JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (16)
- JJY Multi-Analyte Controls, All Kinds (Assayed) (16)
- JIT Calibrator, Secondary (13)