FDA Device Intelligence
Home › MARDX DIAGNOSTICS, INC. › TrinityBiotech

TrinityBiotech

MARDX DIAGNOSTICS, INC. · Model 1206620 · UDI-DI 05391516746342

MHJ
1
510(k) clearances
5
Adverse events
1
Recalls
14
Facilities

Description

Uni-Gold™ Cryptosporidium, 20 Tests

Recalls

DateFirmReason
2002-05-09Remel, Inc.A potential stability problem has been identified with the Positive Controls in the referenced kit lots of the ProSpecT Cryptosporidium Microplate Assay. The Positive Control may

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.