Identity
- Trade Name
- Anti TPO Ab ELISA FDA UDI
- Generic Name
- Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Anti TPO Ab ELISA is a test system for the quantitative measurement of IgG class autoantibodies against thyroid peroxidase (TPO) in human serum or plasma. FDA UDI
- Model / Reference
- EIA-3561 FDA UDI
- Description
- Anti TPO Ab ELISA is a test system for the quantitative measurement of IgG class autoantibodies against thyroid peroxidase (TPO) in human serum or plasma. FDA UDI
Identifiers
- Catalog Number
- EIA-3561 FDA UDI
- Primary DI / UDI-DI
- 04048474035612 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
- Not 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
Anti TPO Ab ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
Sources (1)
- FDA UDI ab68a351-e928-4f5c-9bcc-9466d9606d60 37 fields · synced May 30, 2026