Identity
- Trade Name
- DIASTAT anti-Thyroid Peroxidase FDA UDI
- Generic Name
- Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- FTPO300 FDA UDI
Identifiers
- Catalog Number
- FTPO300 FDA UDI
- Primary DI / UDI-DI
- 07340058410134 FDA UDI
- 510(k) Number
- K020687 FDA UDI
- FDA Product Code
- JZO FDA UDI
- GMDN Term
- Thyroid peroxidase antibody (anti-TPO/microsomal 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
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)
DIASTAT anti-Thyroid Peroxidase by Euro-Diagnostica AB — Class II — 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).
- ELISA TPO IgG Test System — ZEUS SCIENTIFIC, INC.
- Gold Standard Diagnostics Is-Anti-TPO IgG ELISA Test Kit — Gold Standard Diagnostics, LLC · Class II
- ELISA TPO IgG Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- 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
Cleared under the same submission
K020687 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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Euro-Diagnostica AB
Sources (1)
- FDA UDI fbe1ffd6-571b-466e-b8c4-f1eab4f981d1 34 fields · synced Jun 6, 2026