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Rite Aid 8025004

by Rite Aid Corporation

Rite Aid 8025004 is a total human chorionic gonadotropin IVD (FDA Class II; FDA product code LCX, Kit, Test, Pregnancy, Hcg, Over The Counter) made by Rite Aid Corporation, cleared under FDA 510(k) K123050 on 5 Feb 2013 and listed in FDA GUDID since 9 Feb 2023 (UDI-DI 00011822887069), active as of 23 Oct 2026.

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) K123050

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00011822887069 UDI-DI Date9 Feb 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123050 Date5 Feb 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123050 decided 5 Feb 2013 Active
  • FDA GUDID UDI-DI 00011822887069 listed 9 Feb 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123050
  2. Listed FDA GUDID 00011822887069

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Rite Aid
Generic name
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Model / reference
8025004
Primary DI / UDI-DI
00011822887069
510(k) Number
FDA product code
LCX
GMDN term
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
862.1155
GUDID distribution status
In Commercial Distribution

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Properties

  • Single use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)