Data / Medical devices / Canada / Affinity Biologicals Inc.
Affinity Biologicals Inc.: FDA-registered device maker in ANCASTER Ontario, Canada, 2 510(k) clearances
Affinity Biologicals Inc. is registered with the FDA (registration 3003485232) in ANCASTER Ontario, Canada. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 20, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003485232
- Address
- 1348 Sandhill Drive, ANCASTER Ontario, Canada, L9G 4V5
- Owner or operator
- AFFINITY BIOLOGICALS INC. (9072541)
- Roles
- Manufacturer
- First device listed
- July 20, 2005
- Registered through
- 2026
- Brand names listed
- Sheep anti-FXIII-IG-ASR (SAFXIII-IG-ASR-5), Sheep anti-FXIII-IG-ASR (SAFXIII-IG-ASR-500), VISULIZE FACTOR IX ANTIGEN KIT, VISULIZE FACTOR VIII ANTIGEN KIT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Reagents, Specific, Analyte | MVU | 1 | Manufacturer | accessdata.fda.gov |
| Test, Qualitative And Quantitative Factor Deficiency | GGP | 2 | 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 |
|---|---|---|---|---|---|---|
| January 20, 2006 | K052825 | VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG | GGP | Substantially Equivalent | Affinity Biologicals, Inc. | accessdata.fda.gov |
| June 29, 2005 | K051054 | VISULIZE FACTOR IX ANTIGEN KIT | GGP | Substantially Equivalent | Affinity Biologicals, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Test, Qualitative And Quantitative Factor Deficiency
- All makers of Reagents, Specific, Analyte
Updated January 20, 2006. 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.