Identity
- Trade Name
- uTASWako AFP-L3 FDA UDI
- Generic Name
- Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, reagent FDA UDI
- Device Name
- In-Vitro Diagnostic Use FDA UDI
- Model / Reference
- 999-60601 FDA UDI
- Description
- In-Vitro Diagnostic Use FDA UDI
Identifiers
- Catalog Number
- 999-60601 FDA UDI
- Primary DI / UDI-DI
- 00856626006205 FDA UDI
- 510(k) Number
- K100464 FDA UDI
- FDA Product Code
- NSF FDA UDI
- GMDN Term
- Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.6030 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
uTASWako AFP-L3 by Fujifilm Wako Pure Chemical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K100464 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fujifilm Wako Pure Chemical Corporation
Sources (1)
- FDA UDI 4473edc7-cb94-413b-8b53-f762cb31e54d 38 fields · synced May 30, 2026