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e.p.t. Early Pregnancy Test e.p.t. Analog

by Nfi Consumer Products

Listed FDA GUDID listing, not in commercial distribution

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 Number00045611953031 UDI-DI Date28 Nov 2017ListedStatusListed GUDID: not 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  • Withdrawn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
e.p.t. Early Pregnancy Test
Generic Name
Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA)
Model / Reference
e.p.t. Analog
Primary DI / UDI-DI
00045611953031
FDA Product Code
LCX
GMDN Term
Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA)
Device Class
Class II
Regulation Number
862.1155
GUDID distribution status
Not in Commercial Distribution

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