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First Sign® Fsccup-264

by Hemosure Inc.

First Sign® Fsccup-264 is a Class II device made by Hemosure Inc., listed in FDA GUDID since 7 Oct 2016 (UDI-DI 00817763020615), 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 Number00817763020615 UDI-DI Date7 Oct 2016ListedStatusListed 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  • Withdrawn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-264
Primary DI / UDI-DI
00817763020615
FDA product code
JXM, DKE, DIO, DJG, DJC, DKZ
GMDN term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
862.3170, 862.3870, 862.3250, 862.3650, 862.3610, 862.3100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Similar devices in this category

Other devices filed under Multiple drugs of abuse IVD, kit, rapid ICT, clinical.

Other devices from Hemosure Inc.

See all devices from Hemosure Inc. →

Properties

  • Single use
  • Prescription use
  • Over-the-counter
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)