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510(k) Data Aggregation
K Number
K112120Device Name
DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
Manufacturer
DIAZYME LABORATORIES
Date Cleared
2013-01-24
(549 days)
Product Code
GHH, DAP, JIT
Regulation Number
864.7320Why did this record match?
Product Code :
GHH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The D-Dimer Assay is for the quantitative determination of fibrin degradation products (D-Dimer) in human plasma. Measurement of D-Dimer is used as an aid in detecting the presence of intravascular coagulation and fibrinolysis. For in vitro diagnostic use only.
The Diazyme D-Dimer Calibrator Set is intended for use of the calibration of the Diazyme D-Dimer Assay only. For in vitro diagnostic use only.
The Diazyme D-Dimer Control Set is intended for use as quantitative quality controls for the Diazyme D-Dimer Assay only. For in vitro diagnostic use only.
Device Description
Diazyme's D-Dimer Assay is based on a latex enhanced immunoturbidimetric assay. D-Dimer proteins in the sample bind to the specific anti-D-Dimer antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of D-Dimer in the sample. The instrument calculates the D-Dimer concentration of a patient specimen by interpolation of the obtained signal of a 6-point calibration curve.
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K Number
K072288Device Name
PATHFAST D-DIMER
Manufacturer
MITSUBISHI KAGAKU IATRON
Date Cleared
2009-05-06
(629 days)
Product Code
GHH
Regulation Number
864.7320Why did this record match?
Product Code :
GHH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K070453Device Name
OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL
Manufacturer
OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH
Date Cleared
2007-06-11
(115 days)
Product Code
GHH
Regulation Number
864.7320Why did this record match?
Product Code :
GHH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
System reagent for the quantitative determination of D-Dimer in human plasma on OLYMPUS analyzers.
Aid in detecting the presence and degree of intravascular coagulation and fibrinolysis, and in monitoring therapy for disseminated intravascular coagulation.
Device Description
In this Olympus procedure, the decrease in light intensity transmitted (increase in absorbance) through particles suspended in solution is as a result of complexes formed during the immunological reaction between the D-Dimer of the patient serum and the anti-human D-Dimer antibodies coated on the latex particles
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K Number
K062203Device Name
TINA-QUANT D-DIMER TEST SYSTEM
Manufacturer
ROCHE DIAGNOSTICS CORP.
Date Cleared
2007-03-14
(225 days)
Product Code
GHH
Regulation Number
864.7320Why did this record match?
Product Code :
GHH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers. In conjunction with a non-high clinical probability assessment, a normal (< 0.5 µg FEU/ml) result excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity.
Device Description
The Tina-Quant® D-Dimer test system is an immunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers. Latex particles of uniform size are coated with monoclonal antibodies (F(ab')2 fragments) to the D-Dimer epitope. The antigen/antibody complexes produced by the addition of samples containing D-dimer lead to an increase in the turbidity of the test reactants, which can be determined turbidimetrically. The calibrator is D-Dimer calibrator and the recommended control material is D-dimer Control I/II.
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K Number
K042890Device Name
TRIAGE D-DIMER TEST, MODEL 98100
Manufacturer
BIOSITE INCORPORATED
Date Cleared
2004-11-29
(41 days)
Product Code
GHH, DAP
Regulation Number
864.7320Why did this record match?
Product Code :
GHH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Triage® D-Dimer Test is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of crosslinked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
Device Description
The Triage® D-Dimer Test is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens.
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K Number
K030740Device Name
MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
Manufacturer
ROCHE DIAGNOSTICS CORP.
Date Cleared
2003-04-01
(22 days)
Product Code
GHH
Regulation Number
864.7320Why did this record match?
Product Code :
GHH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Immunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers in plasma.
Device Description
The Tina-quant® D-Dimer Test system is a particle enhanced immunoturbidimetric assay. Latex particles are coated with monoclonal antibodies to the D-Dimer epitope. The antigen/antibody complexes produced by the addition of samples containing D-Dimer lead to an increase in turbidity.
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K Number
K021877Device Name
MDA D-DIMER
Manufacturer
BIOMERIEUX, INC.
Date Cleared
2002-08-07
(61 days)
Product Code
GHH
Regulation Number
864.7320Why did this record match?
Product Code :
GHH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MDA® D-Dimer is a homogeneous latex particle based immunoassay for the quantitative determination of crosslinked fibrin degradation products containing the D-dimer domain in citrated human plasma. MDA D-Dimer is an assay for use in conjunction with a clinical Pre-test Probability Assessment (PTP) model in excluding deep vein thrombosis (DVT) in outpatients suspected of a first episode of DVT. MDA D-Dimer can also be used as and in the assessment and evaluation of patients suspected of pulmonary embolism (PE). The assay is designed for use on the MDA automated coagulation analyzers.
Device Description
bioMerieux Inc. MDA® D-Dimer is a homogeneous latex particle based immunoassay for the quatitative determination of cross-linked fibrin degradation products containing the D-dimer domain in citrated human plasma. These latex particles aggregate in the presence of fibrin derivatives containing the D-dimer domain. The rate of latex microparticle aggregation is proportional to the concentration of D-dimer in the sample. D-dimer concentration may be interpolated from a reference curve.
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K Number
K011143Device Name
TINA-QUANT D-DIMER TEST SYSTEM
Manufacturer
ROCHE DIAGNOSTICS CORP.
Date Cleared
2001-05-29
(46 days)
Product Code
GHH
Regulation Number
864.7320Why did this record match?
Product Code :
GHH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993276Device Name
SIMPLIFY D-DIMER, MODEL DCGK1
Manufacturer
AGEN BIOMEDICAL LTD.
Date Cleared
1999-12-14
(75 days)
Product Code
GHH
Regulation Number
864.7320Why did this record match?
Product Code :
GHH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Simplify D-dimer test is a rapid immunochromatography test for the qualitative detection of D-dimer (fibrin degradation products containing the cross-linked Ddimer site) in human whole blood and plasma. The test is intended for use as an aid in the diagnosis of disseminated intravascular coagulation, deep vein thrombosis and pulmonary embolism.
Device Description
The Simplify D-dimer test is a rapid immunochromatography test for the qualitative detection of D-dimer (fibrin degradation products containing the cross-linked Ddimer site) in human whole blood and plasma.
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K Number
K972316Device Name
OPUS D-DIMER
Manufacturer
BEHRING DIAGNOSTICS, INC.
Date Cleared
1997-09-09
(81 days)
Product Code
GHH
Regulation Number
864.7320Why did this record match?
Product Code :
GHH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OPUS D-Dimer is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of cross-linked fibrin degradation products (XL-FDP) containing D-Dimer in human plasma, used in the diagnosis of thromboembolic events. OPUS D-Dimer is intended for use with the OPUS analyzers.
Device Description
OPUS D-Dimer is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of cross-linked fibrin degradation products containing D-Dimer in human plasma.
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