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VALIDATE 1003ro

by LGC Clinical Diagnostics, Inc.

VALIDATE 1003ro is a Class I device made by LGC Clinical Diagnostics, Inc., listed in FDA GUDID since 13 Dec 2024 (UDI-DI 00850011135563), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850011135563 UDI-DI Date13 Dec 2024ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Validate
Generic name
Free testosterone IVD, control
Model / reference
1003ro
Primary DI / UDI-DI
00850011135563
FDA product code
JJY
GMDN term
Free testosterone IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Progesterone IVD, controlEstradiol (oestradiol) (E2) IVD, controlDehydroepiandrosterone sulfate (DHEAS) IVD, controlAndrostenedione IVD, control

Similar devices

Other devices filed under FDA product code JJY (Multi-Analyte Controls, All Kinds (Assayed)).

Other devices from LGC Clinical Diagnostics, Inc.

See all devices from LGC Clinical Diagnostics, Inc. →

Properties

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