Data / Medical devices / United States / Antibodies Incorporated
Antibodies Incorporated: FDA-registered device maker in Davis, CA, United States, 1 510(k) clearance
Antibodies Incorporated is registered with the FDA (registration 2914537) in Davis, CA, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 1, 1981. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2914537
- Address
- 25242 County Road 95, Davis, CA, United States, 95616
- Owner or operator
- Antibodies Incorporated (2914537)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 4, 2007
- Registered through
- 2027
- Brand names listed
- Anti-hTERT Antibody (SCD-A7), AntiNuclear Antibody Test (ANA), BD Detergent Solution Concentrate, BD Sheath Additive, CrithiDNA, FACS LYSING SOLUTION
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | DHN | 2 | Manufacturer | accessdata.fda.gov |
| Counter, Cell, Automated (Particle Counter) | GKL | 2 | Contract manufacturer | accessdata.fda.gov |
| Counter, Differential Cell | GKZ | 2 | Contract manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Contract manufacturer | accessdata.fda.gov |
| Immunohistochemistry Reagents And Kits | NJT | 1 | Contract manufacturer | accessdata.fda.gov |
| Products, Red-Cell Lysing Products | GGK | 1 | Contract manufacturer | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 1, 1981 | K812314 | CRITHIDNA ANTI-DNA TEST KIT | DHN | Substantially Equivalent | Antibodies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Counter, Differential Cell
- All makers of General Purpose Reagent
- All makers of Counter, Cell, Automated (Particle Counter)
- All makers of Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- All makers of Products, Red-Cell Lysing Products
- All makers of Reagents, Specific, Analyte
Updated September 1, 1981. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.