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David Lh-S01

by Equinox Biotech Co., 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 Number06938444982818 UDI-DI Date1 Jun 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  • Withdrawn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
David
Generic Name
Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Model / Reference
LH-S01
Primary DI / UDI-DI
06938444982818
FDA Product Code
NGE
GMDN Term
Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Device Class
Class I
Regulation Number
862.1485
GUDID distribution status
In Commercial Distribution

Other devices from Equinox Biotech Co., Ltd.

See all devices from Equinox Biotech Co., Ltd. →

Properties

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

Other properties (8)

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