GNAClass I

Antisera, All Types, Escherichia Coli

Microbiology · 21 CFR 866.3255

MDR events0All time

Recalls1All time

Registered firms18Currently listed

510(k) clearances12All 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

1 recall events for this product code

Meridian Bioscience Inc
TerminatedJan 17, 2017
PREMIER EHEC and PREMIER EHEC Bulk.
Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.
Z-1033-2017 · View FDA record ↗

Registered firms

18 firms currently registered for this product code

510(k) clearances

12 clearances for this product code