Identity
- Trade Name
- EL-anti-TPO FDA UDI
- Generic Name
- Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ANTI-THYROPEROXIDASE (TPO) ANTIBODY ELISA TEST KIT, 192 TESTS FDA UDI
- Model / Reference
- 104-119 FDA UDI
- Description
- ANTI-THYROPEROXIDASE (TPO) ANTIBODY ELISA TEST KIT, 192 TESTS FDA UDI
Identifiers
- Catalog Number
- 104-119 FDA UDI
- Primary DI / UDI-DI
- 00854473003255 FDA UDI
- 510(k) Number
- K090760 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
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
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)
EL-anti-TPO by Theratest Laboratories, 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).
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- ReQuest — QUEST INTERNATIONAL, INC. · Class II
- QUANTA Lite® TPO ELISA — INOVA DIAGNOSTICS, INC. · Class II
- 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
Cleared under the same submission
K090760 also covers:
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
- Theratest Laboratories, Inc.
Sources (1)
- FDA UDI efe585d7-baf8-450f-95cf-432c7f07e445 36 fields · synced May 30, 2026