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μTASWako AFP-L3 Sample Dilution Buffer
EUDAMEDFDA UDIClass A (EU MDR)
Ref 997-61501
Identity
- Trade Name
- μTASWako AFP-L3 Sample Dilution Buffer EUDAMEDuTASWako AFP-L3 Sample Dilution Buffer FDA UDI
- Generic Name
- Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- μTASWako AFP-L3 Sample Dilution Buffer EUDAMEDIn-Vitro Diagnostic Use FDA UDI
- Model / Reference
- 997-61501 EUDAMEDFDA UDI
- Description
- In-Vitro Diagnostic Use FDA UDI
Identifiers
- Catalog Number
- 997-61501 FDA UDI
- Primary DI / UDI-DI
- 14987481164465 EUDAMEDFDA UDI
- Basic UDI-DI
- 498748114987481164465ZN EUDAMED
- 510(k) Number
- K100464 FDA UDI
- FDA Product Code
- NSF FDA UDI
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
- GMDN Term
- Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 866.6030 FDA UDI
- Market of Registration
- Germany 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
Yes
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
μTASWako AFP-L3 Sample Dilution Buffer by Fujifilm Wako Pure Chemical Corporation — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 498748114987481164465ZN | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- FUJIFILM Wako Pure Chemical Corporation
- EUDAMED SRN
- JP-MF-000013944
- Authorised Representative
- FUJIFILM Wako Chemicals Europe GmbH DE-AR-000011552
Sources (2)
- EUDAMED 4bc03cc0-96b2-4784-830e-cd4f6aa80d70 61 fields · synced Jun 18, 2026
- FDA UDI 2ea8f3d1-d024-4207-9a6d-25ea112535c4 37 fields · synced May 29, 2026