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Walgreens 761016

by Walgreen Co.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K231795

FDA submission, from GUDID

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 Number00311917080062 UDI-DI Date26 Aug 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK231795 Date22 Mar 2024DecidedStatusActive

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  • Withdrawn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 — FDA 510(k) Active

Specification

GUDID

Trade name
Walgreens
Generic name
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Model / reference
761016
Primary DI / UDI-DI
00311917080062
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 (K231795)

Other devices from Walgreen Co.

See all devices from Walgreen Co. →

Properties

  • Single use
  • Prescription use
  • Over-the-counter
  • Convenience kit
  • Lot / batch number
  • Expiration date

Other properties (9)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No