Duns Number:064039514
Device Description: The SonACT Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coagulation &
Catalog Number
800-0432
Brand Name
Sonoclot® SonACT Kit
Version/Model Number
800-0432
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K952560,K952560
Product Code
JPA
Product Code Name
System, Multipurpose For In Vitro Coagulation Studies
Public Device Record Key
cb2d6cd7-95df-4617-9bb4-212962024a76
Public Version Date
July 27, 2021
Public Version Number
1
DI Record Publish Date
July 19, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 11 |