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Advin COVID-19 Antigen Test @Home ABCASS(1)-CAN-AO-25T

by Advin Biotech

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 NumberB115ABCASS1CANAO25T1 UDI-DI Date29 Dec 2025ListedStatusListed 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  • Withdrawn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
Advin COVID-19 Antigen Test @Home
Generic Name
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Model / Reference
ABCASS(1)-CAN-AO-25T
Primary DI / UDI-DI
B115ABCASS1CANAO25T1
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

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Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No