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BRUCELLA ABORTUS ANTIGEN
GERMAINE LABORATORIES, INC · Model 1000 · UDI-DI 00695684010003
GSO
Prescription
10
510(k) clearances
0
Adverse events
2
Recalls
5
Facilities
Description
Brucella Abortus Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2004-10-20 | BD Diagnostic Systems | Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. |
| 2004-10-20 | BD Diagnostic Systems | Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.