FDA.reportPublic FDA data

Sonoclot® aiACT Kit

Primary DI
B55880004411
Brand
Sonoclot® aiACT Kit
Company
SIENCO, INC.
Model
800-0441
Catalog number
800-0441
Device description
The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood.The aiACT Kit is only intended for high dose (ACT greater or equal to 400 seconds, on Sonoclot Analyzer) heparin anticoagulation management as typically encountered during cardiopulmonary bypass surgery. The aiACT test provides ACT results that are substantially unaffected by aprotinin. When used with the Sonoclot Analyzer System, the aiACT test provides quantitative Onset/ACT and Clot Rate results. Do not use the aiACT test for platelet function assessment. Each kit contains 24 lidded yellow plastic activation cuvettes, 24 probes, and instructions for use. The activation cuvettes contain a controlled amount of contact activator 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

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B55880004411PrimaryHIBCC0
B55880004410Unit 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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000558338HR HTCMEDTRONIC, INC.JBP2026-02-23
20763000558332HR HTCMEDTRONIC, INC.JBP2026-02-23
00763000558192CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
00763000558208CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
00763000558215CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
00763000558222CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
00763000558239CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
20763000558196CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
20763000558202CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
20763000558219CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
20763000558226CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
20763000558233CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
B558DP29510Sonoclot® Coagulation & Platelet Function AnalyzerSIENCO, INC.JBP2023-06-28
20763000433813LR-ACTMEDTRONIC, INC.JBP2023-04-08
20763000433844HR-ACTMEDTRONIC, INC.JBP2023-04-08
00763000433819LR-ACTMEDTRONIC, INC.JBP2023-04-08
00763000433840HR-ACTMEDTRONIC, INC.JBP2023-04-08
20763000441450NAMEDTRONIC, INC.JBP2023-04-07
00763000441456NAMEDTRONIC, INC.JBP2023-04-07
10711234103401GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)ACCRIVA DIAGNOSTICS HOLDINGS, INC.JBP2022-01-21
10711234103418GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR)ACCRIVA DIAGNOSTICS HOLDINGS, INC.JBP2022-01-21
00711234103404GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)ACCRIVA DIAGNOSTICS HOLDINGS, INC.JBP2022-01-21
00711234103411GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR)ACCRIVA DIAGNOSTICS HOLDINGS, INC.JBP2022-01-21
20643169730155N/AMEDTRONIC, INC.JBP2021-11-12
00643169730151N/AMEDTRONIC, INC.JBP2021-11-12
B55880004421Sonoclot® aiACT KitSIENCO, INC.JBP2021-07-19
B55880004410Sonoclot® aiACT KitSIENCO, INC.JBP2021-07-19
B55880004420Sonoclot® aiACT KitSIENCO, INC.JBP2021-07-19
B55880004111Sonoclot® gbACT+ KitSIENCO, INC.JBP2021-05-26
B55880004121Sonoclot® gbACT+ KitSIENCO, INC.JBP2021-05-26