Identity
- Trade Name
- uTASWako Wash Solution FDA UDI
- Generic Name
- Immunohistochemistry wash buffer reagent IVD FDA UDI
- Device Name
- In-Vitro Diagnostic Use FDA UDI
- Model / Reference
- 991-60801 FDA UDI
- Description
- In-Vitro Diagnostic Use FDA UDI
Identifiers
- Catalog Number
- 991-60801 FDA UDI
- Primary DI / UDI-DI
- 10856626006059 FDA UDI
- 510(k) Number
- K100464 FDA UDI
- FDA Product Code
- NSF FDA UDI
- GMDN Term
- Immunohistochemistry wash buffer reagent IVD 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
uTASWako Wash Solution 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 4a7f8a9b-5f99-44fa-a52f-97d0cbf9d081 38 fields · synced Jun 8, 2026