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METHAMP

RANDOX LABORATORIES LIMITED · Model DA4007 · UDI-DI 05055273208009

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

Description

The Methamphetamine assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of methamphetamine in human urine.

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.