Identity
- Trade Name
- Anti-Thyroid Peroxidase (Anti-TPO) ELISA FDA UDI
- Generic Name
- Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Quantitative Determination of Thyroid Peroxidase (TPO) Autoantibodies in Human Serum or Plasma by a Microplate Enzyme Immunoassay. Measurements of TPO autoantibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto’s and Grave’s as well as nontoxic goiter. FDA UDI
- Model / Reference
- EIA-4114 FDA UDI
- Description
- The Quantitative Determination of Thyroid Peroxidase (TPO) Autoantibodies in Human Serum or Plasma by a Microplate Enzyme Immunoassay. Measurements of TPO autoantibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto’s and Grave’s as well as nontoxic goiter. FDA UDI
Identifiers
- Catalog Number
- EIA-4114 FDA UDI
- Primary DI / UDI-DI
- 00840239041142 FDA UDI
- FDA Product Code
- JNL FDA UDI
- GMDN Term
- Multiple thyroid 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 8 Milliliter FDA UDITotal Volume — 13 Milliliter FDA UDITotal Volume — 7 Milliliter FDA UDITotal Volume — 20 Milliliter FDA UDITotal Volume — 1 Milliliter FDA UDI
Category: Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)
Anti-Thyroid Peroxidase (Anti-TPO) ELISA by DRG International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA).
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- Anti TG Ab ELISA — DRG 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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- DRG International, Inc.
Sources (1)
- FDA UDI e8be4073-76d5-4529-8de7-2c7f51fb7d8d 36 fields · synced May 29, 2026