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Antisera, Fluorescent, Brucella Spp.
FDA product code GSM · Class 2 · Microbiology
8
Registered devices
1
Adverse events
4
Recalls
4
510(k) clearances
Devices with this code
Anti-Brucella abortus ELISA (IgA) — EUROIMMUN Medizinische Labordiagnostika AGAnti-Brucella abortus ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AGGSD Brucella IgG ELISA — Gold Standard Diagnostics CorporationLT Brucella Antisera Test Reagents — Zhuhai Longtime Biological Technology Co., LtdBRUCELLA ABORTUS ANTISERUM — GERMAINE LABORATORIES, INCAnti-Brucella abortus ELISA (IgM) — EUROIMMUN Medizinische Labordiagnostika AGLT Brucella Antisera Test Reagents — Zhuhai Longtime Biological Technology Co., LtdNovaLisa Brucella IgG — Gold Standard Diagnostics Frankfurt GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-08-27 | Calbiotech Inc | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard rel |
| 2008-08-27 | Calbiotech Inc | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard rel |
| 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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