Duns Number:078431936
Device Description: Tasso+ convenience kit allows self-collection of a capillary blood sample that is shipped Tasso+ convenience kit 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
K1016-01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
b03ee06f-322b-43cd-b4a7-db4bfac53ee0
Public Version Date
December 29, 2021
Public Version Number
1
DI Record Publish Date
December 21, 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 |