Sonoclot® kACT Kit 800-0401

GUDID B55880004010

The kACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The kACT test is a kaolin activated whole blood clotting time test. It may also be used with citrated whole blood and plasma. The kACT Kit is intended for high dose heparin management with or without aprotinin. The kACT test provides quantitative Onset/ACT and Clot Rate results with the Sonoclot Analyzer. The kACT test is not intended for platelet function monitoring. Each kit contains 24 lidded blue plastic activation cuvettes, 24 probes, and instructions for use. The activation cuvettes contain a controlled amount of kaolin and a magnetic stir bar.

SIENCO, INC.

Multiple coagulation factor IVD, kit, clotting

• Primary Device ID: B55880004010
• NIH Device Record Key: 8ddc9c4a-ebdb-49b5-8ec2-fe3829b06bbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonoclot® kACT Kit
• Version Model Number: 800-0401
• Catalog Number: 800-0401
• Company DUNS: 064039514
• Company Name: SIENCO, INC.
• Device Count: 24
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 303-420-1148
• Email: info@sienco.com
• Phone: 303-420-1148
• Email: info@sienco.com
• Phone: 303-420-1148
• Email: info@sienco.com
• Phone: 303-420-1148
• Email: info@sienco.com
• Phone: 303-420-1148
• Email: info@sienco.com
• Phone: 303-420-1148
• Email: info@sienco.com
• Phone: 303-420-1148
• Email: info@sienco.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B55880004010 [Unit of Use]
HIBCC	B55880004011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952560

FDA Product Code

• JPA: System, Multipurpose For In Vitro Coagulation Studies

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-27
• Device Publish Date: 2021-07-19

On-Brand Devices [Sonoclot® kACT Kit]

• B55880004010: The kACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet
• B55880004001: The kACT Kit is an in vitro diagnostic test for use with the Sonoclot Coagulation & Platelet Fun