FDA Device Intelligence
Home › Wolfe & Associates Inc › RealityCHECK Drugs of Abuse Cup

RealityCHECK Drugs of Abuse Cup

Wolfe & Associates Inc · Model RC10TCA · UDI-DI 00868401000261

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

Description

(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO 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.