CLIAwaived

Cliawaived, Inc. · Model CLIA-12-RDTC-A · UDI-DI 00816610021058

LAF LDJ DIO DJG DJC DKZ JXM LFG LCM DIS DJR Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Rapid Drug Test Cup for (THC/COC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Adulteration Tests CR, NI, PH, BL, SG

Recalls

Date	Firm	Reason
2021-02-05	OraSure 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 key Read 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.