FDA Device Intelligence
Home › TECO DIAGNOSTICS › TECO DIAGNOSTICS

TECO DIAGNOSTICS

TECO DIAGNOSTICS · Model URS-9-100 · UDI-DI 10673486000382

JMTCDMJIRCENJIOJREJINJJBJIL Prescription
1
510(k) clearances
7
Adverse events
2
Recalls
80
Facilities

Description

URS-9-100 FINISHED KIT

Recalls

DateFirmReason
2023-05-22Universal Meditech Inc.Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri
2023-05-22Universal Meditech Inc.Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri

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.