Sonoclot® SonACT Kit

Primary DI
B55880004310
Brand
Sonoclot® SonACT Kit
Company
SIENCO, INC.
Model
800-0431
Catalog number
800-0431
Device description
The SonACT Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The SonACT test is a celite activated whole blood clotting time test. It may also be used with citrated whole blood and plasma. The SonACT 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 up to high heparin levels (0 to approximately 6 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening. When used with the Sonoclot Analyzer System, the SonACT 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 24 lidded colorless plastic activation cuvettes, 24 probes, and instructions for use. The activation cuvettes contain a controlled amount of celite and a magnetic stir bar.
Published
2021-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JPASystem, Multipurpose For In Vitro Coagulation Studies

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPASystem, Multipurpose For In Vitro Coagulation StudiesHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B55880004311PrimaryHIBCC0
B55880004310Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation factor IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen, using a clotting method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
303-420-1148info@sienco.com

Regulatory Flags#

DUNS number
064039514
Device count
24
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B55880004011Sonoclot® kACT Kit800-0401800-04012021-07-19
B55880004111Sonoclot® gbACT+ Kit800-0411800-04112021-05-26
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
B558DP29510Sonoclot® Coagulation & Platelet Function AnalyzerDP-29512023-06-28
B55880004010Sonoclot® kACT Kit800-0401800-04012021-07-19
B55880004250Sonoclot® NonActivated Kit800-0425800-04252021-07-19
B55880004260Sonoclot® NonActivated Kit800-0426800-04262021-07-19
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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