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First Sign®

HEMOSURE INC. · Model FSCDIP1724 · UDI-DI 00817763022206

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

Description

DOA 2 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure, CLIA Waived AMP/mAMP

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.