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CareSuperb COVID-19/FluA&B Antigen Combo Test RCNM-02071

by Access Bio, Inc.

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

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 Number00850010224442 UDI-DI Date8 Jun 2026ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 Test
Generic Name
Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing
Model / Reference
RCNM-02071
Primary DI / UDI-DI
00850010224442
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

Other devices from Access Bio, Inc.

See all devices from Access Bio, Inc. →

Properties

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

Other properties (9)

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