GQHClass II

Antigen, Cf (including Cf Control), Cytomegalovirus

Microbiology · 21 CFR 866.3175

MDR events2All time

Recalls1All time

Registered firms6Currently listed

510(k) clearances19All time

Recent MDR events

2 adverse event reports on file

PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FANNov 1, 2013
MalfunctionZimmer Surgical1526350-2013-00642
CMV IGM CAPTUREApr 12, 2006
MalfunctionDiamedix Corporation714338

Event type breakdown

Malfunction2

Most-reported manufacturers

Diamedix Corporation1 Zimmer Surgical1

Recalls

1 recall events for this product code

Bion Enterprises Ltd
TerminatedJun 5, 2013
Plastic bottle containing 10.5 mL of IgM Conjugate
Affected products have a labeled expiration date of one year too long.
Z-1478-2013 · View FDA record ↗

Registered firms

6 firms currently registered for this product code

510(k) clearances

19 clearances for this product code