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Thyretain 40-1005K.V2

by Diagnostic Hybrids, Inc.

Ref 40-1005K.v2Model Thyretain

Thyretain 40-1005K.V2 is a device classified as IVD General (EU), Class II (US) made by Diagnostic Hybrids, Inc., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI B-30014613331490) and listed in FDA GUDID since 7 Aug 2018 (UDI-DI 30014613331490), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-30014613331490 Basic UDI-DI 30014613331490UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30014613331490 UDI-DI Date7 Aug 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-30014613331490 registered 22 Oct 2026 Active
  • FDA GUDID UDI-DI 30014613331490 listed 7 Aug 2018 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 30014613331490
  2. Registered EUDAMED B-30014613331490

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Thyretain TSI Reporter BioAssay EUDAMED
Thyretain GUDID
Generic name
Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay
Device name
TSI Reporter BioAssay
Model / Ref / Catalog
40-1005K.V2, Thyretain
Primary DI / UDI-DI
30014613331490
Basic UDI-DI
B-30014613331490
FDA product code
JZO
EMDN code
W0102100304 Thyroid stimulating immunoglobulin
GMDN term
Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
866.5870
EU registration type
Legacy device (under a directive)
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

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

Similar devices in this category

Other devices filed under THYROID-AUTO-IMMUNE DISEASE.

Other devices from Diagnostic Hybrids, Inc.

See all devices from Diagnostic Hybrids, Inc. →

Properties

  • Single use
  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (15, all answered No)