JZHClass II

Factor B, Antigen, Antiserum, Control

Immunology · 21 CFR 866.5320

MDR events0All time

Recalls1All time

Registered firms6Currently listed

510(k) clearances6All 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

Diagnostic Hybrids Inc
TerminatedSep 3, 2015
MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.
Z-0417-2015 · View FDA record ↗

Registered firms

6 firms currently registered for this product code

510(k) clearances

6 clearances for this product code