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Brucella IgG ELISA

DRG International Inc · Model EIA-3455 · UDI-DI 00840239034557

GSO Prescription
10
510(k) clearances
0
Adverse events
2
Recalls
5
Facilities

Description

The DRG Brucella IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Brucella in human serum and plasma.

Recalls

DateFirmReason
2004-10-20BD Diagnostic SystemsFebrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
2004-10-20BD Diagnostic SystemsFebrile 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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Data 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.