GRPClass II
Antisera, All Types, H. Influenza
Microbiology · 21 CFR 866.3300
MDR events11All time
Recalls1All time
Registered firms6Currently listed
510(k) clearances6All time
Recent MDR events
11 adverse event reports on file
- BD DIFCO¿ HAEMOPHILUS INFLUENZAE ANTISERUM TYPE DMar 26, 2024MalfunctionLee Laboratories, Inc.1025402-2024-00005
- BD DIFCO¿ HAEMOPHILUS INFLUENZAE ANTISERUM TYPE DMar 26, 2024MalfunctionLee Laboratories, Inc.1025402-2024-00007
- BD DIFCO¿ HAEMOPHILUS INFLUENZAE ANTISERUM TYPE DMar 26, 2024MalfunctionLee Laboratories, Inc.1025402-2024-00006
- BD DIFCO¿ HAEMOPHILUS INFLUENZAE ANTISERUM TYPE DMar 13, 2024MalfunctionLee Laboratories, Inc.1025402-2024-00003
- BD DIFCO¿ HAEMOPHILUS INFLUENZAE ANTISERUM TYPE DMar 13, 2024MalfunctionLee Laboratories, Inc.1025402-2024-00004
- BD DIFCO¿ HAEMOPHILUS INFLUENZAE ANTISERUM TYPE DMar 5, 2024MalfunctionLee Laboratories, Inc.1025402-2024-00002
- RSVFeb 15, 2007MalfunctionBinax, Inc.824135
- REMEL XPECT INFLUENZA A&B KITApr 19, 2006MalfunctionRemelMW1038748
- ED EZFLUJan 25, 2006OtherBecton DickinsonMW1037842
- WAMPOLEOct 26, 2005OtherWampoleMW1037020
Event type breakdown
Malfunction8
Other3
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
6 firms currently registered for this product code
510(k) clearances
6 clearances for this product code
- Armkel, LLCFeb 7, 1989
K884967 · BACTIGEN(R) H. INFLUENZAE TYPE B
- American Micro ScanDec 27, 1985
K854490 · IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES
- Seragen Diagnostics, Inc.Sep 29, 1983
K831525 · H-FLU B ELISA TEST
- Diagnostica, Inc.Dec 28, 1982
K823348 · H. INFLUENZA B ANTISERA FOR CIE
- Bd Becton Dickinson Vacutainer Systems PreanalyticJun 1, 1982
K821266 · BBL DIRECTIGEN MENINGITIS TEST KIT
- Hyland Therapeutic Div., Travenol LaboratoriesMar 11, 1982
K820192 · HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM