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Thyretain 40-1025.V2

by Diagnostic Hybrids, Inc.

Thyretain 40-1025.V2 is a Class II device made by Diagnostic Hybrids, Inc., cleared under FDA 510(k) K092229 on 18 May 2010 and listed in FDA GUDID since 7 Aug 2018 (UDI-DI 30014613331506), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K092229

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number30014613331506 UDI-DI Date7 Aug 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK092229 Date18 May 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K092229 decided 18 May 2010 Active
  • FDA GUDID UDI-DI 30014613331506 listed 7 Aug 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K092229
  2. Listed FDA GUDID 30014613331506

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Thyretain
Generic name
Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay
Model / Ref / Catalog
40-1025.V2
Primary DI / UDI-DI
30014613331506
510(k) Number
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

Cleared under the same submission (K092229)

and 3 more cleared under K092229

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)