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U-Screen

Instant Tech Subsidiary Acquisition · Model USSCupA-5M · UDI-DI 00858998006142

LAFDKZDJGDIOLDJ Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
64
Facilities

Description

U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 5 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET)

Recalls

DateFirmReason
2021-02-05OraSure Technologies, Inc.Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.