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CareSuperb COVID-19 Antigen Home Test RCTM-00271

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 Number00850010224305 UDI-DI Date5 Jan 2026ListedStatusListed 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  • Withdrawn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 Antigen Home Test
Generic Name
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Model / Reference
RCTM-00271
Primary DI / UDI-DI
00850010224305
510(k) Number
FDA Product Code
QYT
GMDN Term
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Device Class
Class II
Regulation Number
866.3984
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K241915)

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