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Cl Aia-Pack Sample Diluting Reagent D
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 0029404
Identity
- Trade Name
- CL AIA-PACK SAMPLE DILUTING REAGENT D EUDAMEDFDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- CL AIA-PACK SAMPLE DILUTING REAGENT D EUDAMED
- Model / Reference
- 0029404 EUDAMEDn/a FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14562185399650 EUDAMEDFDA UDI
- Basic UDI-DI
- B-14562185399650 EUDAMED45601892100010267A EUDAMED
- FDA Product Code
- GIF FDA UDI
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
- GMDN Term
- Buffered sample diluent IVD FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.8200 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
New Device
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Cl Aia-Pack Sample Diluting Reagent D by Tosoh Corporation — Class IVD General — IVDR, IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-14562185399650 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-14562185399650 | 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 (3)
- EUDAMED 454d5654-356a-4be5-9763-d43be12d1a96 61 fields · synced Jul 29, 2026
- EUDAMED 578c5cb2-5390-4e48-8ec6-3289c6aa6859 61 fields · synced May 17, 2026
- FDA UDI 5072718b-5631-450e-858a-6f29ab8a7d1d 34 fields · synced May 30, 2026