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TSH Receptor Autoantibody ELISA

FDA UDI

Class II (US FDA UDI)

by DRG International, Inc.

Identity

Trade Name
TSH Receptor Autoantibody ELISA FDA UDI
Generic Name
Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The TSH receptor (TSHR) autoantibody (TRAb) ELISA kit is intended for use by professional persons only for the quantitative determination of TRAb in human serum FDA UDI
Model / Reference
EIA-3369 FDA UDI
Description
The TSH receptor (TSHR) autoantibody (TRAb) ELISA kit is intended for use by professional persons only for the quantitative determination of TRAb in human serum FDA UDI

Identifiers

Catalog Number
EIA-3369 FDA UDI
Primary DI / UDI-DI
00840239033697 FDA UDI
510(k) Number
K032134 FDA UDI
FDA Product Code
JZO FDA UDI
GMDN Term
Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, enzyme immunoassay (EIA) 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

Yes

FDA UDI

Category: Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, enzyme immunoassay (EIA)

TSH Receptor Autoantibody ELISA by DRG International, 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, enzyme immunoassay (EIA).

Cleared under the same submission

K032134 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DRG International, Inc.

Sources (1)

  • FDA UDI cfc13a58-4af3-42d9-af89-3fd6ce9c9966 37 fields · synced Jun 7, 2026