LSOClass II

Dna-reagents, Cytomegalovirus

Microbiology · 21 CFR 866.3175

MDR events2All time

Recalls1All time

Registered firms0Currently listed

510(k) clearances0All time

Recent MDR events

2 adverse event reports on file

Event type breakdown

Other2

Most-reported manufacturers

Abbott Laboratories2

Recalls

1 recall events for this product code

Digene Corp
TerminatedJul 20, 2004
Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing test reagents for performing 60 tests. Digene Catalog #4403-2003
In vitro diagnostic test kit may produce false negative clinical results.
Z-1039-04 · View FDA record ↗

Registered firms

0 firms currently registered for this product code

No registered firms found for this product code.

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for this product code.