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μTASWako AFP-L3 Control H
EUDAMEDFDA UDIClass C (EU MDR)
Ref 993-61101Model 999-60601, 997-60901, 997-61001, 993-61101
Identity
- Trade Name
- μTASWako AFP-L3 Control H EUDAMEDuTASWako AFP-L3 Control H FDA UDI
- Generic Name
- Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, control FDA UDI
- Device Name
- μTASWako AFP-L3, μTASWako AFP-L3 Calibrator Set, μTASWako AFP-L3 Control L, μTASWako AFP-L3 Control H EUDAMEDIn-Vitro Diagnostic Use FDA UDI
- Model / Reference
- 999-60601, 997-60901, 997-61001, 993-61101 EUDAMED993-61101 EUDAMEDFDA UDI
- Description
- In-Vitro Diagnostic Use FDA UDI
Identifiers
- Catalog Number
- 993-61101 FDA UDI
- Primary DI / UDI-DI
- 14987481164458 EUDAMEDFDA UDI
- Basic UDI-DI
- 49874814987481164390UP EUDAMED
- 510(k) Number
- K100464 FDA UDI
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0102152005 TUMOUR MARKER CONTROLS EUDAMED
- GMDN Term
- Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, control FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 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
Yes
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 Control H by Fujifilm Wako Pure Chemical Corporation — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 49874814987481164390UP | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | 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 294ec287-7644-4625-9208-b42e06182894 61 fields · synced Oct 6, 2026
- FDA UDI 9ee2347f-e83b-483b-a435-199eaafd5690 37 fields · synced May 30, 2026