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PROTEUS OX2 ANTIGEN

GERMAINE LABORATORIES, INC · Model 1201 · UDI-DI 00695684012014

GSY Prescription
0
510(k) clearances
0
Adverse events
2
Recalls
2
Facilities

Description

Proteus OX2 Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection.

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.