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CorDx Tyfast ACT21013

by Coretests, Inc.

CorDx Tyfast ACT21013 is a Class II device made by Coretests, Inc., listed in FDA GUDID since 7 Mar 2025 (UDI-DI 00850042559772), 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 Number00850042559772 UDI-DI Date7 Mar 2025ListedStatusListed 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  • Withdrawn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
CorDx Tyfast
Generic name
Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing
Model / reference
ACT21013
Primary DI / UDI-DI
00850042559772
FDA product code
LCX, NGE
GMDN term
Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing
Device class
Class II
Regulation number
862.1155, 862.1485
GUDID distribution status
In Commercial Distribution

Related devices

Category: Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testingTotal human chorionic gonadotropin IVD, kit, rapid ICT, self-testing

Similar devices

Other devices filed under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter).

Other devices from Coretests, Inc.

See all devices from Coretests, Inc. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)