GNWClass I

Antisera, Cf, Influenza Virus A, B, C

Microbiology · 21 CFR 866.3330

MDR events0All time

Recalls2All time

Registered firms10Currently listed

510(k) clearances16All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

2 recall events for this product code

Millipore Corporation
TerminatedMar 6, 2009
LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit
Certain lots of Simulfluor Flu A / Flu B Reagent may cross-react with Respiratory Synctial Virus. The continued use of Simulfluor Flu A / Flu B Reagent Catalog #5250 may lead to a potential misdiagnosis of influenza B.
Z-0953-2009 · View FDA record ↗
Millipore Corporation
TerminatedMar 6, 2009
LIGHT DIAGNOSTICS Simulfluor Flu A / Flu B 2 mL Reagent Catalog # 5250 which is a component in the Kit Catalog #3121 Simulfluor Flu A / Flu B DFA kit.
Certain lots of Simulfluor Flu A / Flu B Reagent may cross-react with Respiratory Synctial Virus. The continued use of Simulfluor Flu A / Flu B Reagent Catalog #5250 may lead to a potential misdiagnosis of influenza B.
Z-0954-2009 · View FDA record ↗

Registered firms

10 firms currently registered for this product code

510(k) clearances

16 clearances for this product code