Identity
- Trade Name
- DIASTAT anti-thyroglobulin FDA UDI
- Generic Name
- Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- FATG200 FDA UDI
Identifiers
- Catalog Number
- FATG200 FDA UDI
- Primary DI / UDI-DI
- 07340058410110 FDA UDI
- 510(k) Number
- K952183 FDA UDI
- FDA Product Code
- JZO 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
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)
DIASTAT anti-thyroglobulin by Euro-Diagnostica AB — 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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- ELISA Tg IgG Test System — ZEUS SCIENTIFIC, INC.
- Anti-Thyroid Peroxidase (Anti-TPO) ELISA — DRG International, Inc. · Class II
- Anti-Thyroglobulin (Anti-Tg) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- ELISA Tg IgG Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- Anti TG Ab ELISA — DRG International, Inc. · Class II
- Anti TG Ab ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
Cleared under the same submission
K952183 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 4c86fa21-c26e-4fc0-be20-d99f2d78956f 34 fields · synced May 31, 2026