Identity
- Trade Name
- μTASWako Chip Cassette EUDAMEDuTASWako Chip Cassette FDA UDI
- Generic Name
- Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- μTASWako Chip Cassette EUDAMEDThe uTASWako chip cassette is designed to be used for the assays on the uTASWako i30. FDA UDI
- Model / Reference
- 993-61601 EUDAMEDFDA UDI
- Description
- The uTASWako chip cassette is designed to be used for the assays on the uTASWako i30. FDA UDI
Identifiers
- Catalog Number
- 993-61601 FDA UDI
- Primary DI / UDI-DI
- 14987481164427 EUDAMEDFDA UDI
- Basic UDI-DI
- 498748114987481164427ZE EUDAMED
- 510(k) Number
- K100464 FDA UDI
- FDA Product Code
- NSF FDA UDI
- EMDN Code
- W0201020185 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES 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
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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 Chip Cassette by Fujifilm Wako Pure Chemical Corporation — Class A — 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 | 498748114987481164427ZE | 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 2216dade-8818-4a07-b108-57bedc6b2f01 61 fields · synced Jun 19, 2026
- FDA UDI b2fd4d72-ce8c-441f-8ad3-33d3802e864e 37 fields · synced May 30, 2026