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iCup™

Instant Technologies, Inc. · Model DUA-187-012 · UDI-DI 00817405022892

LAFDKZDIODISDJGJXMLDJLCM Prescription
10
510(k) clearances
0
Adverse events
1
Recalls
64
Facilities

Description

MDML Screen Test Card with the Integrated iCup with AD Strips

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.