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Thyretain

FDA UDI

Class II (US FDA UDI)

by Diagnostic Hybrids, Inc.

Identity

Trade Name
Thyretain FDA UDI
Generic Name
Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay FDA UDI
Device Name
Thretain TSI Reporter Bioassay 25P FDA UDI
Model / Reference
Thyretain FDA UDI
Description
Thretain TSI Reporter Bioassay 25P FDA UDI

Identifiers

Catalog Number
40-25000.V2 FDA UDI
Primary DI / UDI-DI
30014613331537 FDA UDI
FDA Product Code
JZO FDA UDI
GMDN Term
Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5870 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Thyretain by Diagnostic Hybrids, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diagnostic Hybrids, Inc.

Sources (1)

  • FDA UDI b5e0af77-16ce-445c-a560-9b4480003159 35 fields · synced Jun 8, 2026