Duns Number:078431936
Device Description: Tasso+ allows self-collection of a capillary blood sample that is shipped to an accredited Tasso+ allows self-collection of a capillary blood sample that is shipped to an accredited laboratory for analysis.
Catalog Number
-
Brand Name
Tasso+ Convenience Kit
Version/Model Number
K1011-03
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 30, 2022
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
-
Product Code
PQD
Product Code Name
Blood Specimen Collection Convenience Kit (Excludes Hiv)
Public Device Record Key
9ba5ef73-c048-436a-ade8-c6c9aff2df86
Public Version Date
October 31, 2022
Public Version Number
3
DI Record Publish Date
May 10, 2021
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |