Sonoclot® Coagulation & Platelet Function Analyzer

Primary DI
B558DP29510
Brand
Sonoclot® Coagulation & Platelet Function Analyzer
Company
SIENCO, INC.
Model
DP-2951
Device description
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.
Published
2023-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JBPActivated Whole Blood Clotting Time

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JBPActivated Whole Blood Clotting TimeHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002528000
K223635000
K952560000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002528000SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTIONSienco, Inc.2000-08-31JBP
K223635000Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot ViewerSienco, Inc.2023-01-04JBP
K952560000SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZERSienco, Inc.1995-09-05JPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B558DP29510PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation analyser IVD, point-of-care, line-poweredA mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used exclusively at the point-of-care by medical professionals for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as whole blood prothrombin time (WBPT), whole blood partial thromboplastin time (WBPTT), heparin dose response, activated clotting time (ACT)]. It may include spectrophotometry, turbidimetry, nephelometry, electrometry and/or mechanical means of clot formation or end point detection.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3034201148info@sienco.com

Regulatory Flags#

DUNS number
064039514
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B55880004011Sonoclot® kACT Kit800-0401800-04012021-07-19
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B55880004121Sonoclot® gbACT+ Kit800-0412800-04122021-05-26
B55880004251Sonoclot® NonActivated Kit800-0425800-04252021-07-19
B55880004261Sonoclot® NonActivated Kit800-0426800-04262021-07-19
B55880004311Sonoclot® SonACT Kit800-0431800-04312021-07-19
B55880004321Sonoclot® SonACT Kit800-0432800-04322021-07-19
B55880004411Sonoclot® aiACT Kit800-0441800-04412021-07-19
B55880004421Sonoclot® aiACT Kit800-0442800-04422021-07-19
B55890013021Sonoclot® Reference Viscosity Oil Quality Control Kit900-1302900-13022021-07-19
B55880004001Sonoclot® kACT Kit800-0400800-04002021-07-19
B55890013181Sonoclot® Reference Plasma Quality Control Kit900-1318900-13182021-07-19
B55880004010Sonoclot® kACT Kit800-0401800-04012021-07-19
B55880004250Sonoclot® NonActivated Kit800-0425800-04252021-07-19
B55880004260Sonoclot® NonActivated Kit800-0426800-04262021-07-19
B55880004310Sonoclot® SonACT Kit800-0431800-04312021-07-19
B55880004320Sonoclot® SonACT Kit800-0432800-04322021-07-19
B55880004410Sonoclot® aiACT Kit800-0441800-04412021-07-19
B55880004420Sonoclot® aiACT Kit800-0442800-04422021-07-19
B55890013020Sonoclot® Reference Viscosity Oil Quality Control Kit900-1302900-13022021-07-19

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