First Sign®

HEMOSURE INC. · Model FSCCUP-13124 W/AD8 · UDI-DI 00817763022220

LCM LDJ LAF DJG DJR DKZ DIS JXM DIO Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

DOA 12 in 1 Test Cup W/AD, 25Pcs/Box; First Sign for Hemosure, CLIA Waived AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC/NI-CR-SG-PH

Recalls

Date	Firm	Reason
2005-05-31	Applied Biotech Inc	The firm has discovered that a number of distributed devices of the Medplus ER Drug Screen Test may be incorrectly assembled which may give incorrect results. The product is an in

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.