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FEBRILE NEGATIVE CONTROL

GERMAINE LABORATORIES, INC · Model 1601 · UDI-DI 00695684016012

GSN Prescription
3
510(k) clearances
1
Adverse events
2
Recalls
4
Facilities

Description

Febrile Negative Control is intended for use as a negative control for Febrile Antigen tests.

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.