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ANTI-THYROGLOBULIN TEST KIT (TgAb)

FDA UDI

Class II (US FDA UDI)

by Kronus, Inc.

Identity

Trade Name
ANTI-THYROGLOBULIN TEST KIT (TgAb) FDA UDI
Generic Name
Thyroglobulin antibody IVD, kit, radioimmunoassay FDA UDI
Device Name
A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroglobulin(Tg) in human serum. FDA UDI
Model / Reference
KR6275 FDA UDI
Description
A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroglobulin(Tg) in human serum. FDA UDI

Identifiers

Catalog Number
KR6275 FDA UDI
Primary DI / UDI-DI
B126KR62750 FDA UDI
FDA Product Code
JZO FDA UDI
GMDN Term
Thyroglobulin antibody IVD, kit, radioimmunoassay 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

No

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: Thyroglobulin antibody IVD, kit, radioimmunoassay

ANTI-THYROGLOBULIN TEST KIT (TgAb) by Kronus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thyroglobulin antibody IVD, kit, radioimmunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kronus, Inc.

Sources (1)

  • FDA UDI cefa8c64-bb8b-45d1-bdf4-98bf714a81ee 35 fields · synced May 30, 2026