JZJClass I

Prealbumin, Antigen, Antiserum, Control

Immunology · 21 CFR 866.5060

MDR events5All time

Recalls1All time

Registered firms40Currently listed

510(k) clearances11All time

Recent MDR events

5 adverse event reports on file

Event type breakdown

Malfunction5

Most-reported manufacturers

Beckman Coulter Inc.2 Roche Diagnostics2 Ortho-clinical Diagnostics1

Recalls

1 recall events for this product code

Abbott Laboratories Diagnostic Div
TerminatedJan 11, 2006
Clinical Chemistry Prealbumin, List Number 1E02-20
These specific protein assays are not meeting the 57-day on board stability claim
Z-0385-06 · View FDA record ↗

Registered firms

40 firms currently registered for this product code

510(k) clearances

11 clearances for this product code