FDA Device Intelligence
Home › Diagnostic Automation, Inc. › AccuDiag ™

AccuDiag ™

Diagnostic Automation, Inc. · Model DACD8207-35 · UDI-DI 00894175000626

MDT
0
510(k) clearances
0
Adverse events
1
Recalls
16
Facilities

Description

AccuDiag™ Trichinella IgG ELISA - For the qualitative detection of immunoglobulin G (IgG) antibodies to the parasitic nematode Trichinella species in a clinical specimen, using an enzyme immunoassay (EIA) method.

Recalls

DateFirmReason
2020-04-22BIOSENSE WEBSTERMapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.

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 docs
Data 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.