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Thyretain 40-100200.V2

by Diagnostic Hybrids, Inc.

Thyretain 40-100200.V2 is a Class II device made by Diagnostic Hybrids, Inc., listed in FDA GUDID since 7 Aug 2018 (UDI-DI 30014613331483), 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 Number30014613331483 UDI-DI Date7 Aug 2018ListedStatusListed 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  • Withdrawn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
Thyretain
Generic name
Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay
Model / Ref / Catalog
40-100200.V2
Primary DI / UDI-DI
30014613331483
FDA product code
JZO
GMDN term
Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay
Device class
Class II
Regulation number
866.5870
GUDID distribution status
In Commercial Distribution

Related devices

Category: Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay

Similar devices

Other devices filed under FDA product code JZO (SYSTEM, TEST, THYROID AUTOANTIBODY).

Other devices from Diagnostic Hybrids, Inc.

See all devices from Diagnostic Hybrids, Inc. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)