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CVS Health Digital & One Step Pregnancy Test Kit

by Woonsocket Prescription Center, Incorporated 2 variants

Listed FDA GUDID listing, not in commercial distribution

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 Number00050428326787 UDI-DI Date3 Jan 2024ListedStatusListed GUDID: not 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  • Withdrawn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
CVS Health
Generic Name
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Model / Reference
Digital & One Step Pregnancy Test Kit
Primary DI / UDI-DI
00050428326787
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
Not in Commercial Distribution

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Properties

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

Other properties (9)

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