FDA Device Intelligence
Home › Instant Tech Subsidiary Acquisition › ProScreen

ProScreen

Instant Tech Subsidiary Acquisition · Model PSDA-8CM5 · UDI-DI 00858998006357

LAFLDJDJGDJCDIODKZLCM Prescription
10
510(k) clearances
0
Adverse events
1
Recalls
65
Facilities

Description

Drugs of Abuse Test Card, (PCP/AMP)+COC150+MDMA+MET500+OPI2000+OXY+THC50 with Cr, Ni, pH, Bl, S.G.

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

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.