DBLClass II

Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

Immunology · 21 CFR 866.5660

MDR events1All time

Recalls1All time

Registered firms15Currently listed

510(k) clearances24All time

Recent MDR events

1 adverse event reports on file

RPG ANTIBODYDec 20, 1997
OtherAtlantic AntibodiesMW1012686

Event type breakdown

Other1

Most-reported manufacturers

Atlantic Antibodies1

Recalls

1 recall events for this product code

Bio-Rad Laboratories
TerminatedSep 19, 2008
Kallestad (TM) Mouse Kidney. Product labeled "BIO-RAD Kallestad (TM) Mouse Kidney Substrate... UNITED STATES, Bio-Rad Laboratories, Redmond, WA 98052... FRANCE
The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit.
Z-2430-2008 · View FDA record ↗

Registered firms

15 firms currently registered for this product code

510(k) clearances

24 clearances for this product code