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ST AIA-PACK Homocysteine CALIBRATOR SET
EUDAMEDFDA UDIFDA 510(k)Class IVD General (EU MDR)
Ref 0025326510(k) K121533
Identity
- Trade Name
- ST AIA-PACK Homocysteine Calibrator Set FDA UDI
- Generic Name
- Homocysteine IVD, calibrator FDA UDI
- Device Name
- ST AIA-PACK Homocysteine CALIBRATOR SET EUDAMED
- Model / Reference
- 0025326 EUDAMEDN/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560189212787 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04560189212787 EUDAMED
- FDA Product Code
- JIT FDA UDI
- EMDN Code
- W0103020614 HOMOCYSTEINE EUDAMED
- GMDN Term
- Homocysteine IVD, calibrator FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1150 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
Yes
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 CALIBRATOR SET by Tosoh Corporation — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121533 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-04560189212787 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Tosoh Corporation
- EUDAMED SRN
- JP-MF-000024143
- FDA Applicant
- Tosoh Bioscience, Inc.
- Authorised Representative
- Tosoh Europe N.V. BE-AR-000000211
Sources (3)
- EUDAMED 743d2d89-158a-4669-892b-76f843f5bcf9 85 fields · synced Jun 18, 2026
- FDA UDI ea4ab106-7771-47cb-847c-f7e114905a36 34 fields · synced May 30, 2026
- FDA 510(k) K121533 1 fields · synced May 18, 2026