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ImmunoWELL Thyroglobulin IgG Quantitative Test

FDA UDI

Class II (US FDA UDI)

by Genbio

Identity

Trade Name
ImmunoWELL Thyroglobulin IgG Quantitative Test FDA UDI
Generic Name
Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The ImmunoWELL Thyroglobulin IgG Quantitative Test is a quantitative enzyme immunoassay (EIA) for screening and detection of autoantibodies against human thyroglobulin in serum and is used as an aid in the diagnosis of thyroid disorders. FDA UDI
Model / Reference
800-3030 FDA UDI
Description
The ImmunoWELL Thyroglobulin IgG Quantitative Test is a quantitative enzyme immunoassay (EIA) for screening and detection of autoantibodies against human thyroglobulin in serum and is used as an aid in the diagnosis of thyroid disorders. FDA UDI

Identifiers

Catalog Number
3030 FDA UDI
Primary DI / UDI-DI
00613745030302 FDA UDI
FDA Product Code
JNL FDA UDI
GMDN Term
Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5870 FDA UDI
Commercial Distribution
Not 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

ImmunoWELL Thyroglobulin IgG Quantitative Test by Genbio — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Genbio

Sources (1)

  • FDA UDI 1d85cebd-2c7a-4e49-9920-aae352617e29 38 fields · synced Jun 8, 2026