Home GUDID B55880004110 Sonoclot® gbACT+ Kit
Primary DI B55880004110
Brand Sonoclot® gbACT+ Kit
Company SIENCO, INC.
Model 800-0411
Catalog number 800-0411
Device description The gbACT+ Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The gbACT+ test is a glass bead activated whole blood clotting time test. It may also be used with citrated whole blood and plasma. Warning: The gbACT+ test is not intended for high dose heparin management during cardiopulmonary bypass surgery. The gbACT+ 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 at low to moderate heparin levels (0 to 2 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening. When used with the Sonoclot Analyzer System, the gbACT+ 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 pink plastic activation cuvettes, 24 probes, and instructions for use. The activation cuvettes contain a controlled amount of glass beads and a magnetic stir bar.
Published 2021-05-26
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 JBP Activated Whole Blood Clotting Time
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JBP Activated Whole Blood Clotting Time Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B55880004111 Primary HIBCC 0 B55880004110 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 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 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 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
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00763000558338 HR HTC MEDTRONIC, INC. JBP 2026-02-23 20763000558332 HR HTC MEDTRONIC, INC. JBP 2026-02-23 00763000558192 CLOTtrac™ MEDTRONIC, INC. JBP 2026-02-22 00763000558208 CLOTtrac™ MEDTRONIC, INC. JBP 2026-02-22 00763000558215 CLOTtrac™ MEDTRONIC, INC. JBP 2026-02-22 00763000558222 CLOTtrac™ MEDTRONIC, INC. JBP 2026-02-22 00763000558239 CLOTtrac™ MEDTRONIC, INC. JBP 2026-02-22 20763000558196 CLOTtrac™ MEDTRONIC, INC. JBP 2026-02-22 20763000558202 CLOTtrac™ MEDTRONIC, INC. JBP 2026-02-22 20763000558219 CLOTtrac™ MEDTRONIC, INC. JBP 2026-02-22 20763000558226 CLOTtrac™ MEDTRONIC, INC. JBP 2026-02-22 20763000558233 CLOTtrac™ MEDTRONIC, INC. JBP 2026-02-22 B558DP29510 Sonoclot® Coagulation & Platelet Function Analyzer SIENCO, INC. JBP 2023-06-28 20763000433813 LR-ACT MEDTRONIC, INC. JBP 2023-04-08 20763000433844 HR-ACT MEDTRONIC, INC. JBP 2023-04-08 00763000433819 LR-ACT MEDTRONIC, INC. JBP 2023-04-08 00763000433840 HR-ACT MEDTRONIC, INC. JBP 2023-04-08 20763000441450 NA MEDTRONIC, INC. JBP 2023-04-07 00763000441456 NA MEDTRONIC, INC. JBP 2023-04-07 10711234103401 GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+) ACCRIVA DIAGNOSTICS HOLDINGS, INC. JBP 2022-01-21 10711234103418 GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR) ACCRIVA DIAGNOSTICS HOLDINGS, INC. JBP 2022-01-21 00711234103404 GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+) ACCRIVA DIAGNOSTICS HOLDINGS, INC. JBP 2022-01-21 00711234103411 GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR) ACCRIVA DIAGNOSTICS HOLDINGS, INC. JBP 2022-01-21 20643169730155 N/A MEDTRONIC, INC. JBP 2021-11-12 00643169730151 N/A MEDTRONIC, INC. JBP 2021-11-12 B55880004411 Sonoclot® aiACT Kit SIENCO, INC. JBP 2021-07-19 B55880004421 Sonoclot® aiACT Kit SIENCO, INC. JBP 2021-07-19 B55880004410 Sonoclot® aiACT Kit SIENCO, INC. JBP 2021-07-19 B55880004420 Sonoclot® aiACT Kit SIENCO, INC. JBP 2021-07-19 B55880004111 Sonoclot® gbACT+ Kit SIENCO, INC. JBP 2021-05-26
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