GSYClass I
Antisera, Fluorescent, All Globulins, Proteus Spp.
Microbiology · 21 CFR 866.3410
MDR events0All time
Recalls2All time
Registered firms2Currently listed
510(k) clearances0All 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
- BD Diagnostic SystemsTerminatedDec 16, 2004
BD, Proteus OX19 Antigen
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Z-0319-05 · View FDA record ↗ - BD Diagnostic SystemsTerminatedDec 16, 2004
BD, Proteus Polyvalent Antiserum (OXK, OX2, OX19)
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Z-0321-05 · View FDA record ↗
Registered firms
2 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.