Sonoclot® gbACT+ Kit - The gbACT+ Kit is an in vitro diagnostic reagent - SIENCO, INC.

Duns Number:064039514

Device Description: The gbACT+ Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coagulation & The gbACT+ Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The gbACT+ test is a glass bead activated whole blood clotting time test. It may also be used with citrated whole blood and plasma. Warning: The gbACT+ test is not intended for high dose heparin management during cardiopulmonary bypass surgery.The gbACT+ Kit is intended for general purpose global hemostasis monitoring including: clot detection, fibrin formation, platelet function, and hyperfibrinolysis. The monitoring information is typically used for anticoagulant management at low to moderate heparin levels (0 to 2 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening.When used with the Sonoclot Analyzer System, the gbACT+ test provides quantitative Onset/ACT and Clot Rate results as well as qualitative and quantitative information on the Sonoclot Signature including: fibrin formation, platelet function, and hyperfibrinolysis.Each kit contains 100 lidded pink plastic activation cuvettes, 100 probes, and instructions for use. The activation cuvettes contain a controlled amount of glass beads and a magnetic stir bar.

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More Product Details

Catalog Number

800-0412

Brand Name

Sonoclot® gbACT+ Kit

Version/Model Number

800-0412

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

K984141,K984141

Product Code Details

Product Code

JBP

Product Code Name

Activated Whole Blood Clotting Time

Device Record Status

Public Device Record Key

a80d3ab6-1de9-4d21-a6a4-1a065a39b6f6

Public Version Date

June 03, 2021

Public Version Number

1

DI Record Publish Date

May 26, 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