DAKClass II

Complement C1q, Antigen, Antiserum, Control

Immunology · 21 CFR 866.5240

MDR events0All time

Recalls3All time

Registered firms12Currently listed

510(k) clearances28All 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

3 recall events for this product code

Inova Diagnostics Incorporated
TerminatedJun 30, 2010
Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021
The recall was initiated after the binding site notified Inova Diagnostics, inc. that the affected Bindazyme Human C1q binding Circulating Immune Complex EIA Kits may contain an ELISA plate labeled as "tissue Transglutaminase Coated Wells" instead of "C1q Coated Wells".
Z-1942-2010 · View FDA record ↗
Diagnostic Hybrids, Inc.
TerminatedUnknown
MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma.
There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.
Z-1496-2018 · View FDA record ↗
Diagnostic Hybrids, Inc.
TerminatedUnknown
MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma.
A component of the kit was found to contain bacterial contamination.
Z-1497-2018 · View FDA record ↗

Registered firms

12 firms currently registered for this product code

510(k) clearances

28 clearances for this product code