Sonoclot® Coagulation & Platelet Function Analyzer

GUDID B558DP29510

The Sonoclot Coagulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software. The Sonoclot Analyzer System rapidly provides information on the entire hemostasis process including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis. The Sonoclot Analyzer System generates a qualitative graph, known as the Sonoclot Signature, and quantitative results on the clot formation time (Activated Clotting Time-Onset), the rate of fibrin polymerization (Clot Rate), and clot retraction (Platelet Function). This information can be used to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effect, hypercoagulable tendencies and hyperfibrinolysis. Different disposable tests are available for use with the Sonoclot Analyzer System for different applications.

SIENCO, INC.

Coagulation analyser IVD, point-of-care, line-powered

• Primary Device ID: B558DP29510
• NIH Device Record Key: c8707be0-417c-4fef-84fd-32c712eb4f76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonoclot® Coagulation & Platelet Function Analyzer
• Version Model Number: DP-2951
• Company DUNS: 064039514
• Company Name: SIENCO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 3034201148
• Email: info@sienco.com
• Phone: 3034201148
• Email: info@sienco.com
• Phone: 3034201148
• Email: info@sienco.com
• Phone: 3034201148
• Email: info@sienco.com
• Phone: 3034201148
• Email: info@sienco.com
• Phone: 3034201148
• Email: info@sienco.com
• Phone: 3034201148
• Email: info@sienco.com
• Phone: 3034201148
• Email: info@sienco.com
• Phone: 3034201148
• Email: info@sienco.com
• Phone: 3034201148
• Email: info@sienco.com
• Phone: 3034201148
• Email: info@sienco.com
• Phone: 3034201148
• Email: info@sienco.com
• Phone: 3034201148
• Email: info@sienco.com
• Phone: 3034201148
• Email: info@sienco.com
• Phone: 3034201148
• Email: info@sienco.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B558DP29510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002528

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: 2023-07-06
• Device Publish Date: 2023-06-28

Devices Manufactured by SIENCO, INC.

• B558DP29510 - Sonoclot® Coagulation & Platelet Function Analyzer: 2023-07-06The Sonoclot Coagulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software. The Sonoclot Analyzer System rapidly provides information on the entire hemostasis process including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis. The Sonoclot Analyzer System generates a qualitative graph, known as the Sonoclot Signature, and quantitative results on the clot formation time (Activated Clotting Time-Onset), the rate of fibrin polymerization (Clot Rate), and clot retraction (Platelet Function). This information can be used to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effect, hypercoagulable tendencies and hyperfibrinolysis. Different disposable tests are available for use with the Sonoclot Analyzer System for different applications.
• B558DP29510 - Sonoclot® Coagulation & Platelet Function Analyzer: 2023-07-06 The Sonoclot Coagulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and plat
• B55880004001 - Sonoclot® kACT Kit: 2021-07-27 The kACT Kit is an in vitro diagnostic test for use with the Sonoclot Coagulation & Platelet Function Analyzer System. The kACT
• B55880004010 - Sonoclot® kACT Kit: 2021-07-27 The kACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The k
• B55880004250 - Sonoclot® NonActivated Kit: 2021-07-27 The Non-Activated Clotting Test Kit contains the necessary components for an in vitro diagnostic test for use with the Sonoclot�
• B55880004260 - Sonoclot® NonActivated Kit: 2021-07-27 The Non-Activated Clotting Test Kit contains the necessary components for an in vitro diagnostic test for use with the Sonoclot�
• B55880004310 - Sonoclot® SonACT Kit: 2021-07-27 The SonACT Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. T
• B55880004320 - Sonoclot® SonACT Kit: 2021-07-27 The SonACT Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. T
• B55880004410 - Sonoclot® aiACT Kit: 2021-07-27 The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The a