JTTClass II

Susceptibility Test Powders, Antimicrobial

Microbiology · 21 CFR 866.1640

MDR events2All time

Recalls1All time

Registered firms2Currently listed

510(k) clearances14All time

Recent MDR events

2 adverse event reports on file

VITEK® 2 AST-N288 TEST KITApr 11, 2017
MalfunctionBiomerieux, Inc1950204-2017-00115
VITEK® 2 AST-N288 TEST KITApr 11, 2017
MalfunctionBiomerieux, Inc1950204-2017-00116

Event type breakdown

Malfunction2

Most-reported manufacturers

Biomerieux, Inc2

Recalls

1 recall events for this product code

Remel Inc
TerminatedUnknown
Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in
Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting.
Z-1921-2016 · View FDA record ↗

Registered firms

2 firms currently registered for this product code

510(k) clearances

14 clearances for this product code

PMA approvals

10 premarket approvals for this product code