Identity
- Trade Name
- ST AIA-PACK Homocysteine FDA UDI
- Generic Name
- Homocysteine IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- ST AIA-PACK Homocysteine EUDAMED
- Model / Reference
- 0025226 EUDAMEDN/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14560189212777 EUDAMEDFDA UDI
- Basic UDI-DI
- B-14560189212777 EUDAMED
- FDA Product Code
- LPS FDA UDI
- EMDN Code
- W0103020614 HOMOCYSTEINE EUDAMED
- GMDN Term
- Homocysteine IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1377 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
ST AIA-PACK Homocysteine by Tosoh Corporation — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-14560189212777 | 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 f47b3874-9e16-44f0-be4b-38462552786b 61 fields · synced Jul 29, 2026
- FDA UDI 3633abe8-88fc-4a4b-bba3-739fa8407894 34 fields · synced May 30, 2026