Sonoclot® Reference Viscosity Oil Quality Control Kit

Primary DI
B55890013021
Brand
Sonoclot® Reference Viscosity Oil Quality Control Kit
Company
SIENCO, INC.
Model
900-1302
Catalog number
900-1302
Device description
The Reference Viscosity Oil QC test is a simple means of verifying proper operation of the Sonoclot Analyzer. This test consists of a two point verification of the electromechanical oscillator and also ensures that the heating control is operating accurately. The two verification points are: 1) Probe-In-Air, and 2) Probe-In-Oil. The Probe-In-Air is the response of the electromechanical oscillator to air. The Probe-In-Oil is the response of the electromechanical oscillator to the reference viscosity liquid. Since the viscosity of the reference viscosity fluid is significantly temperature dependent, the Probe-In-Oil test point also verifies the temperature regulation. The QC test should be run each day the Sonoclot Analyzer is used or as required by your institution. Each Reference Viscosity Quality Control Kit contains 24 cuvettes, 24 probes, 1 vial of reference viscosity oil with end cap, and these instructions. These supplies provide 24 QC tests for the analyzer.
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
JPASystem, Multipurpose For In Vitro Coagulation Studies

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPASystem, Multipurpose For In Vitro Coagulation StudiesHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K952560000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952560000SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZERSienco, Inc.1995-09-05JPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B55890013021PrimaryHIBCC0
B55890013020Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation marker IVD, controlA material which is used to verify the performance of an assay 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.

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
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B55880004310Sonoclot® SonACT Kit800-0431800-04312021-07-19
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B55880004410Sonoclot® aiACT Kit800-0441800-04412021-07-19
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B55890013020Sonoclot® Reference Viscosity Oil Quality Control Kit900-1302900-13022021-07-19

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