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CorDx CO291-8

by Coretests, Inc.

CorDx CO291-8 is a device classified as Not classified made by Coretests, Inc., listed in FDA GUDID since 20 Jan 2023 (UDI-DI 00850042559154), 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 Number00850042559154 UDI-DI Date20 Jan 2023ListedStatusListed 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  • Withdrawn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
Generic name
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Model / reference
CO291-8
Primary DI / UDI-DI
00850042559154
FDA product code
QKP
GMDN term
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Device class
N
GUDID distribution status
In Commercial Distribution

Related devices

Category: SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Other devices from Coretests, Inc.

See all devices from Coretests, Inc. →

Properties

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