Antisera, Fluorescent, Brucella Spp.
Microbiology · 21 CFR 866.3085
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
4 recall events for this product code
- Calbiotech IncTerminatedMar 5, 2010
Brucella IgG ELISA 96 Well Kit, Catalog Number: BA052G
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 related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations.
Z-0982-2010 · View FDA record ↗ - Calbiotech IncTerminatedMar 5, 2010
Brucella IgM ELISA 96 Well Kit, Catalog Number: BA053M
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 related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations.
Z-0983-2010 · View FDA record ↗ - BD Diagnostic SystemsTerminatedDec 16, 2004
BD, Brucella Postive Control Antiserum (AMS)
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Z-0322-05 · View FDA record ↗ - BD Diagnostic SystemsTerminatedDec 16, 2004
BD, Febrile Antigen Negative Control
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Z-0323-05 · View FDA record ↗
Registered firms
6 firms currently registered for this product code
Gold Standard Diagnostics, Llc
Davis, CA, US
Euroimmun Us Inc.
Mountain Lakes, NJ, US
Gold Standard Diagnostics Frankfurt Gmbh
Dietzenbach Hesse, DE
Euroimmun Medizinische Labordiagnostika Ag
Luebeck Schleswig-Holstein, DE
Euroimmun Medizinische Labordiagnostika Ag
Dassow Mecklenburg-Western Pomerania, DE
Germaine Laboratories, Inc.
SAN ANTONIO, TX, US
510(k) clearances
4 clearances for this product code