Home GUDID B55880004260 Sonoclot® NonActivated Kit
Primary DI B55880004260
Brand Sonoclot® NonActivated Kit
Company SIENCO, INC.
Model 800-0426
Catalog number 800-0426
Device description The Non-Activated Clotting Test Kit contains the necessary components for an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. It may be used with native whole blood, citrated whole blood, and plasma. The Non-Activated Kit may either be used as a non-activated clotting test or as a general use test with user provided activators. It is intended for customer designed hemostasis monitoring on the Sonoclot Analyzer. The Non-Activated cuvette allows for coagulation monitoring using tissue activation, thrombin activation, and other custom activators. Some of the applications for the Non-Activated test with the addition of customer determined reagents are monitoring of fibrin formation, fibrinolysis, hyperfibrinolysis and clot retraction. When used with the Sonoclot Analyzer System, the Non-Activated 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 plastic cuvettes, 24 probes, and instructions for use. The cuvettes contain 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 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 B55880004261 Primary HIBCC 0 B55880004260 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Multiple coagulation factor IVD, kit, clotting A 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 Type Low High Condition Storage Environment Temperature 0 Degrees Celsius 25 Degrees Celsius
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 false 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 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 B55880004311 Sonoclot® SonACT Kit 800-0431 800-0431 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 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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