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CareSuperb COVID-19/FluA&B Antigen Combo HomeTest RCUM-02071

by Access Bio, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850010224374 UDI-DI Date30 Sep 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
CareSuperb COVID-19/FluA&B Antigen Combo HomeTest
Generic Name
Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing
Model / Reference
RCUM-02071
Primary DI / UDI-DI
00850010224374
510(k) Number
FDA Product Code
SCA
GMDN Term
Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing
Device Class
Class II
Regulation Number
866.3987
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K251604)

Other devices from Access Bio, Inc.

See all devices from Access Bio, Inc. →

Properties

  • Single Use
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No