Identity
- Trade Name
- ELISA TPO IgG Test System FDA UDI
- Generic Name
- Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ZEUS ELISA Thyroid Peroxidase (TPO) IgG Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibodies to thyroid peroxidase (TPO) 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
- 2Z5051G FDA UDI
- Description
- The ZEUS ELISA Thyroid Peroxidase (TPO) IgG Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibodies to thyroid peroxidase (TPO) 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
- 2Z5051G FDA UDI
- Primary DI / UDI-DI
- 00845533001243 FDA UDI
- GMDN Term
- Thyroid peroxidase antibody (anti-TPO/microsomal 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: Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, enzyme immunoassay (EIA)
ELISA TPO IgG Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, enzyme immunoassay (EIA).
- Gold Standard Diagnostics Is-Anti-TPO IgG ELISA Test Kit — Gold Standard Diagnostics, LLC · Class II
- ReQuest — QUEST INTERNATIONAL, INC. · Class II
- QUANTA Lite® TPO ELISA — INOVA DIAGNOSTICS, INC. · Class II
- EL-anti-TPO — THERATEST LABORATORIES, INC.
- Anti-TPO AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class II
- Kallestad — Bio-Rad Laboratories · Class II
- DIASTAT anti-Thyroid Peroxidase — Euro-Diagnostica AB · Class II
- SeraQuest — QUEST INTERNATIONAL, INC. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA UDI 45fb4032-1e57-4b3d-adde-0b3d7e89e1c0 35 fields · synced May 31, 2026