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Pregnenolone Plus 1 Utak-Sc PREG+1 S F Sd

by UTAK Laboratories Inc.

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 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB800UTAKSCPREG1SFSD0 UDI-DI Date20 Oct 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  • Withdrawn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
Pregnenolone Plus 1
Generic Name
Multiple-type clinical chemistry analyte profile IVD, control
Model / Ref / Catalog
UTAK-SC PREG+1 S F SD
Primary DI / UDI-DI
B800UTAKSCPREG1SFSD0
FDA Product Code
LAS
GMDN Term
Multiple-type clinical chemistry analyte profile IVD, control
Device Class
Class I
Regulation Number
862.3280
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 3 Milliliter

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Properties

  • Contains Latex
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

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