GSNClass II
Antiserum, Positive And Negative Febrile Antigen Control Serum
Microbiology · 21 CFR 866.3085
MDR events1All time
Recalls2All time
Registered firms4Currently listed
510(k) clearances3All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Unspecified1
Most-reported manufacturers
Recalls
2 recall events for this product code
- BD Diagnostic SystemsTerminatedDec 16, 2004
BD, Salmonella Somatic Polyvalent Antiserum (A,B,D)
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Z-0313-05 · View FDA record ↗ - BD Diagnostic SystemsTerminatedDec 16, 2004
BD, Salmonella Flagellar Polyvalent Antiserum (a,b,d)
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Z-0318-05 · View FDA record ↗
Registered firms
4 firms currently registered for this product code
510(k) clearances
3 clearances for this product code