Duns Number:690598875
Device Description: The uTASWako chip cassette is designed to be used for the assays on the uTASWako i30.
Catalog Number
993-61601
Brand Name
uTASWako Chip Cassette
Version/Model Number
993-61601
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 23, 2020
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K100464,K100464
Product Code
NSF
Product Code Name
Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
Public Device Record Key
b0a9243b-d7ca-455f-8382-d91c3eca9219
Public Version Date
October 26, 2020
Public Version Number
5
DI Record Publish Date
November 11, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |