Sonoclot® gbACT+ Kit

Primary DI
B55880004111
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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
K984141000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K984141000GBACT + KITSienco, Inc.1999-05-28JBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B55880004111PrimaryHIBCC0
B55880004110Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation marker IVD, kit, clottingA 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
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Contacts#

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

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 DIBrandModelCatalogPublished
B55880004011Sonoclot® kACT Kit800-0401800-04012021-07-19
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
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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