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FEMALE HORMONE Premium Home Blood Sampling Collection Kit SCK10767

by Randox Laboratories, Ltd.

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05055273220995 UDI-DI Date22 May 2026ListedStatusListed 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  • Withdrawn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
FEMALE HORMONE Premium Home Blood Sampling Collection Kit
Generic Name
Capillary blood collection kit IVD
Model / Ref / Catalog
SCK10767
Primary DI / UDI-DI
05055273220995
FDA Product Code
PQD
GMDN Term
Capillary blood collection kit IVD
Device Class
Class II
Regulation Number
862.1675
GUDID distribution status
In Commercial Distribution

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Properties

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

Other properties (9)

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