Home GUDID B55880004311 Sonoclot® SonACT Kit
Primary DI B55880004311
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 Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name JPA System, Multipurpose For In Vitro Coagulation Studies
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JPA System, Multipurpose For In Vitro Coagulation Studies Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B55880004311 Primary HIBCC 0 B55880004310 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Multiple coagulation marker IVD, kit, clotting A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of multiple makers associated with coagulation including coagulation factors, intermediates and/or their activated components, functional tests [activated partial thromboplastin time (APTT), thrombin time (TT), prothrombin time (PT)] and/or physiological anticoagulants (e.g., antithrombin III) in a clinical specimen, using a clotting method.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 064039514 Device count 24 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B55880004011 Sonoclot® kACT Kit 800-0401 800-0401 2021-07-19 B55880004111 Sonoclot® gbACT+ Kit 800-0411 800-0411 2021-05-26 B55880004121 Sonoclot® gbACT+ Kit 800-0412 800-0412 2021-05-26 B55880004251 Sonoclot® NonActivated Kit 800-0425 800-0425 2021-07-19 B55880004261 Sonoclot® NonActivated Kit 800-0426 800-0426 2021-07-19 B55880004321 Sonoclot® SonACT Kit 800-0432 800-0432 2021-07-19 B55880004411 Sonoclot® aiACT Kit 800-0441 800-0441 2021-07-19 B55880004421 Sonoclot® aiACT Kit 800-0442 800-0442 2021-07-19 B55890013021 Sonoclot® Reference Viscosity Oil Quality Control Kit 900-1302 900-1302 2021-07-19 B55880004001 Sonoclot® kACT Kit 800-0400 800-0400 2021-07-19 B55890013181 Sonoclot® Reference Plasma Quality Control Kit 900-1318 900-1318 2021-07-19 B558DP29510 Sonoclot® Coagulation & Platelet Function Analyzer DP-2951 2023-06-28 B55880004010 Sonoclot® kACT Kit 800-0401 800-0401 2021-07-19 B55880004250 Sonoclot® NonActivated Kit 800-0425 800-0425 2021-07-19 B55880004260 Sonoclot® NonActivated Kit 800-0426 800-0426 2021-07-19 B55880004310 Sonoclot® SonACT Kit 800-0431 800-0431 2021-07-19 B55880004320 Sonoclot® SonACT Kit 800-0432 800-0432 2021-07-19 B55880004410 Sonoclot® aiACT Kit 800-0441 800-0441 2021-07-19 B55880004420 Sonoclot® aiACT Kit 800-0442 800-0442 2021-07-19 B55890013020 Sonoclot® Reference Viscosity Oil Quality Control Kit 900-1302 900-1302 2021-07-19
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