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First Sign FSCCUP-34124

by Hemosure Inc.

First Sign FSCCUP-34124 is a Class II device made by Hemosure Inc., listed in FDA GUDID since 3 Sep 2026 (UDI-DI 00817763022954), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817763022954 UDI-DI Date3 Sep 2026ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
First Sign
Generic name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
FSCCUP-34124
Primary DI / UDI-DI
00817763022954
FDA product code
DKZ, JXM, DJG, DIS, LAF, DIO, DJR, LDJ
GMDN term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
862.3100, 862.3170, 862.3650, 862.3150, 862.3610, 862.3250, 862.3620, 862.3870
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code DKZ (Enzyme Immunoassay, Amphetamine).

Other devices from Hemosure Inc.

See all devices from Hemosure Inc. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)