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CorDx Tyfast ACT21002-2

by Coretests, Inc.

CorDx Tyfast ACT21002-2 is a device classified as Not classified made by Coretests, Inc., listed in FDA GUDID since 13 Jun 2024 (UDI-DI 00850042559550), 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 Number00850042559550 UDI-DI Date13 Jun 2024ListedStatusListed 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  • Withdrawn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
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Model / reference
ACT21002-2
Primary DI / UDI-DI
00850042559550
FDA product code
QMN
GMDN term
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Device class
N
GUDID distribution status
In Commercial Distribution

Related devices

Category: SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testingInfluenza A/B virus antigen IVD, kit, rapid ICT, clinical

Similar devices in this category

Other devices filed under Influenza A/B virus antigen IVD, kit, rapid ICT, clinical.

Other devices from Coretests, Inc.

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Properties

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