Sonoclot® kACT Kit - The kACT Kit is an in vitro diagnostic test for - SIENCO, INC.

Duns Number:064039514

Device Description: The kACT Kit is an in vitro diagnostic test for use with the Sonoclot Coagulation & Platel

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More Product Details

Catalog Number

800-0400

Brand Name

Sonoclot® kACT Kit

Version/Model Number

800-0400

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

JPA

Product Code Name

System, Multipurpose For In Vitro Coagulation Studies

Device Record Status

Public Device Record Key

0c6f222f-0326-42e5-88a9-21cea1d47d50

Public Version Date

July 27, 2021

Public Version Number

1

DI Record Publish Date

July 19, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIENCO, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 11