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Found 6 results
510(k) Data Aggregation
K Number
K251968Device Name
HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL
Manufacturer
Instrumentation Laboratory (IL) Co.
Date Cleared
2025-07-24
(28 days)
Product Code
KQJ
Regulation Number
864.7340Why did this record match?
Product Code :
KQJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K073367Device Name
HEMOSIL FIBRINOGEN-C
Manufacturer
INSTRUMENTATION LABORATORY CO.
Date Cleared
2007-12-27
(27 days)
Product Code
KQJ
Regulation Number
864.7340Why did this record match?
Product Code :
KQJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HemosIL Fibrinogen-C is intended for the quantitative determination of fibrinogen, based on the Clauss method, in human citrated plasma on IL Coagulation Systems. For in vitro diagnostic use.
Device Description
The Fibrinogen-C kit uses an excess of thrombin to convert fibrinogen to fibrin in diluted plasma. At high thrombin and low fibrinogen concentration, the rate of reaction is a function of the fibrinogen concentration.
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K Number
K050928Device Name
DADE THROMBIN REAGENT
Manufacturer
DADE BEHRING, INC.
Date Cleared
2005-06-29
(76 days)
Product Code
KQJ
Regulation Number
864.7340Why did this record match?
Product Code :
KQJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in the quantitative determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies.
Device Description
Fibrinogen is a plasma protein which is converted from a soluble protein to an insoluble polymer by the action of thrombin resulting in the formation of a fibrin clot. The thrombin clotting time of dilute plasma is inversely proportional to the fibrinogen concentration of the plasma. Using this principle, Clauss developed a simple quantitative assay for fibrinogen by measuring the clotting time of dilute plasma when excess thrombin is added. The clotting time obtained is then compared with that of a standardized fibrinogen preparation.
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K Number
K971858Device Name
SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)
Manufacturer
SIGMA DIAGNOSTICS, INC.
Date Cleared
1997-10-09
(142 days)
Product Code
KQJ
Regulation Number
864.7340Why did this record match?
Product Code :
KQJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sigma Diagnostics Fibrinogen Kit is a device used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).
Device Description
The method of Clauss measures the rate of fibrin conversion in the presence of excess thrombin and has been shown to be rapid, sensitive and precise. When diluted plasma is clotted with excess thrombin, the fibrinogen level is inversely proportional to the clotting time, vielding a curvilinear relationship when plotted on loglog paper. A calibration curve prepared from a fibrinogen reference is used to determine the fibrinogen concentration in the test sample.
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K Number
K970189Device Name
FIF TM
Manufacturer
PANBIO, INC.
Date Cleared
1997-05-21
(120 days)
Product Code
KQJ, GIS
Regulation Number
864.7340Why did this record match?
Product Code :
KQJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A fibrinogen determination test is indicated for testing of conditions in which blood coagulation is involved. Such conditions include disseminated intravascular coaagulation, cardiovascular disease and primary fibrinolysis.
Device Description
The ABS, Inc. FiF™ Test is an immunoprecipitation test indicated for the quantitative determination of fibrinogen in human plasma. The FiR™ test employs a monoclonal antibody (Mab), specific for intact (undegraded) plasma fibrinogen. When added to a plasma sample the FiFTM MAb precipitates the fibrinogen from solution. The extent of the immunoprecipitate is determined by measuring the change in sample absorbance (at 340nm) after the addition of the FiFTM antibody. There is a linear correlation between the change in sample O.D. at 340nm and the concentration of fibrinogen in the solution. The test is calibrated using a standardized plasma sample provided with the kit.
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K Number
K965113Device Name
N-ASSAY TIA FIBRINOGEN TEST KIT
Manufacturer
CRESTAT DIAGNOSTICS, INC.
Date Cleared
1997-04-16
(117 days)
Product Code
KQJ, DAZ, GIS
Regulation Number
864.7340Why did this record match?
Product Code :
KQJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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