GNPClass I

Antiserum, Cf, Epstein-barr Virus

Microbiology · 21 CFR 866.3235

MDR events0All time

Recalls2All time

Registered firms6Currently listed

510(k) clearances20All 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

2 recall events for this product code

Diamedix Corporation
TerminatedUnknown
Diamedix Is-EBV-EA-D IgG Test Kit
A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
Z-1687-2016 · View FDA record ↗
Diamedix Corporation
TerminatedUnknown
Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
Contains a gel-like contaminant that may affect product performance.
Z-2574-2018 · View FDA record ↗

Registered firms

6 firms currently registered for this product code

510(k) clearances

20 clearances for this product code