GOYClass I

Antisera, Agglutinating, B. Pertussis, All

Microbiology · 21 CFR 866.3065

MDR events1All time

Recalls1All time

Registered firms3Currently listed

510(k) clearances1All time

Recent MDR events

1 adverse event reports on file

LAP SPONGEMay 20, 1996
InjuryUnknown33955

Event type breakdown

Injury1

Most-reported manufacturers

Recalls

1 recall events for this product code

Remel Europe Ltd.
TerminatedUnknown
Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordetella antisera are suit
Thermo Scientific" Remel" Bordetella pertussis Agglutinating Serum (R30165501/ZM10) is not performing, resulting in the potential for false negative results for serotypes 1 and 3
Z-2920-2020 · View FDA record ↗

Registered firms

3 firms currently registered for this product code

510(k) clearances

1 clearances for this product code

Absorbent Cotton Co., Inc.Dec 4, 1978
K781727 · CHANGE IN STERILIZATION PROCEDURE