Sonoclot® gbACT+ Kit 800-0412

GUDID B55880004120

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.

SIENCO, INC.

Multiple coagulation factor IVD, kit, clotting

• Primary Device ID: B55880004120
• NIH Device Record Key: a80d3ab6-1de9-4d21-a6a4-1a065a39b6f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonoclot® gbACT+ Kit
• Version Model Number: 800-0412
• Catalog Number: 800-0412
• Company DUNS: 064039514
• Company Name: SIENCO, INC.
• Device Count: 100
• 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
• 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
• 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
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B55880004120 [Unit of Use]
HIBCC	B55880004121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984141

FDA Product Code

• JBP: Activated Whole Blood Clotting Time

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: 2021-06-03
• Device Publish Date: 2021-05-26

On-Brand Devices [Sonoclot® gbACT+ Kit]

• B55880004120: The gbACT+ Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coagulation & Plate
• B55880004110: The gbACT+ Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coagulation & Plate