Home › HYCOR BIOMEDICAL LLC › Autostat II Anti-Tissue Transglutaminase IgG
Autostat II Anti-Tissue Transglutaminase IgG
HYCOR BIOMEDICAL LLC · Model FGA26 · UDI-DI 00816879020267
10
510(k) clearances
2
Adverse events
1
Recalls
19
Facilities
Description
96 well ELISA for the detection of Anti-Tissue Transglutaminase IgG antibodies in human serum
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-04-03 | Bio-Rad Labs | An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA when compared to a previous lot of product. The observed elevated bias between th |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.