FDA Device Intelligence
Home › HEMOSURE INC. › FIRST SIGN®

FIRST SIGN®

HEMOSURE INC. · Model FSCW19124 · UDI-DI 00857338006767

LCMDKEDIODJGDJCDKZJXMDISDJR Prescription
10
510(k) clearances
5
Adverse events
1
Recalls
95
Facilities

Description

DOA 12 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure AMP/BARB/BUP/BZO/COC/mAMP/MOR/MTD/OPI/OXY/PCP/THC

Recalls

DateFirmReason
2005-05-31Applied Biotech IncThe 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 keyRead 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.