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.

Customer Support Contacts

Operating and Storage Conditions

Device Identifiers

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984141

FDA Product Code

Sterilization

Device Entry Metadata

On-Brand Devices [Sonoclot® gbACT+ Kit]

Trademark Results [Sonoclot]

Mark Image Registration | Serial	Company Trademark Application Date
SONOCLOT 85825814 4388109 Live/Registered	Sienco, Incorporated 2013-01-17
SONOCLOT 73040018 1039577 Dead/Expired	SIMONS, SANFORD L. 1974-12-20