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AIA-PACK TPOAb/TgAb SAMPLE DILUTING SOLUTION
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 0020590
Identity
- Trade Name
- AIA-PACK TPOAb/TgAb SAMPLE DILUTING SOLUTION FDA UDI
- Generic Name
- Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, reagent FDA UDI
- Device Name
- AIA-PACK TPOAb/TgAb SAMPLE DILUTING SOLUTION EUDAMED
- Model / Reference
- 0020590 EUDAMEDN/A- FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560189211247 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04560189211247 EUDAMED
- FDA Product Code
- JZO FDA UDI
- EMDN Code
- W0102100301 THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES EUDAMED
- GMDN Term
- Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5870 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
AIA-PACK TPOAb/TgAb SAMPLE DILUTING SOLUTION by Tosoh Corporation — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-04560189211247 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Tosoh Corporation
- EUDAMED SRN
- JP-MF-000024143
- Authorised Representative
- Tosoh Europe N.V. BE-AR-000000211
Sources (2)
- EUDAMED 14299060-41e9-4e64-b4e6-96a5d46647fc 61 fields · synced Jul 15, 2026
- FDA UDI 8fe51501-1d62-4519-a15c-722c01ef624a 34 fields · synced May 30, 2026