Identity
- Trade Name
- ELISA Tg IgG Test System FDA UDI
- Generic Name
- Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ZEUS ELISA Thyroglobulin (Tg) IgG Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibody to thyroglobulin in human serum. The test system is intended to be used as an aid in the diagnosis of thyroid diseases. This test is for In Vitro diagnostic use. FDA UDI
- Model / Reference
- 2Z5061G FDA UDI
- Description
- The ZEUS ELISA Thyroglobulin (Tg) IgG Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibody to thyroglobulin in human serum. The test system is intended to be used as an aid in the diagnosis of thyroid diseases. This test is for In Vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 2Z5061G FDA UDI
- Primary DI / UDI-DI
- 00845533001175 FDA UDI
- GMDN Term
- Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- 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: Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)
ELISA Tg IgG Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA).
- Anti-Thyroid Peroxidase (Anti-TPO) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- TPO IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Anti-Thyroid Peroxidase (Anti-TPO) ELISA — DRG International, Inc. · Class II
- Anti-Thyroglobulin (Anti-Tg) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Anti TG Ab ELISA — DRG International, Inc. · Class II
- Anti TG Ab ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Anti-Thyroglobulin (Anti-Tg) ELISA — DRG International, Inc. · Class II
- DIASTAT anti-thyroglobulin — Euro-Diagnostica AB · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA UDI 83b9f35e-8398-4348-bf73-e73f00a89fab 35 fields · synced Jun 1, 2026