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Found 8 results
510(k) Data Aggregation
K Number
K080069Device Name
DIMERTEST
Manufacturer
AMERICAN DIAGNOSTICA, INC.
Date Cleared
2008-02-13
(34 days)
Product Code
DAP
Regulation Number
864.7320Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN DIAGNOSTICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DIMERTEST® Latex Assay is intended for the rapid qualitative or semi-quantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (D-dimer) in human plasma.
Device Description
The DIMERTEST® Latex Kit is a qualitative and semi-quantitative latex agglutination slide test for cross-linked fibrin degradation products in human plasma. The active ingredient in the DIMERTEST® product is the latex reagent. This reagent consists of highly specific D-dimer monoclonal antibodies attached to polystyrene latex particles. When mixed with the latex reagent, the presence of antigen (Ddimer) in a plasma sample results in agglutination of the latex particles which can be seen with the unaided eye. A semi-quantitative estimate of the Ddimer concentration can be made by preparing dilutions of a plasma sample. The concentration is determined according to a titration matrix.
Plasma from normal individuals is not expected to agglutinate DIMERTEST® Latex. Reactive fibrinolysis will be demonstrated by latex agglutination at a plasma concentration of approximately 200 ng/mL D-dimer.
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K Number
K063323Device Name
SPECTROLYSE PAI-1, MODEL 101201
Manufacturer
AMERICAN DIAGNOSTICA, INC.
Date Cleared
2007-08-15
(285 days)
Product Code
GGP
Regulation Number
864.7290Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN DIAGNOSTICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Spectrolyse ® PAI-1 kit, Product # 101201, is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use and is not intended for internal use in humans and animals.
Device Description
Spectrolyse @ PAI-1 is a two stage colorimetric assay. The first stage involves incubating samples with a known amount of tPA, allowing PAI-1 in the sample to react with tPA. In the second stage, the residual tPA activity converts plasminogen to plasmin, which in turn hydrolyzes a plasmin chromogenic substrate, SPECTROZYME® PL. PAI-1 in the plasma is determined as the difference between the amount of tPA added and the amount of tPA recovered.
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K Number
K052124Device Name
ACTICLOT, MODEL 824
Manufacturer
AMERICAN DIAGNOSTICA, INC.
Date Cleared
2005-10-17
(73 days)
Product Code
GJS, GIR
Regulation Number
864.7750Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN DIAGNOSTICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ACTICLOT® dPT™ is intended for the qualitative determination of lupus anticoagulants (LA) in human plasma. This test is for in vitro diagnostic use.
Device Description
ACTICLOT® dPT" is a test kit. It has three reagents that are used selectively for a screening protocol and a confirmatory protocol. LA Buffer" is used with dPT Activator" for the screening protocol. LA Phospholipids" is used with dPT Activator" for the confirmatory protocol. ACTICLOT® dPT" is a professional use qualitative test.
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K Number
K013637Device Name
ACTICHROME HEPARIN (ANTI-FIIA)
Manufacturer
AMERICAN DIAGNOSTICA, INC.
Date Cleared
2002-04-16
(162 days)
Product Code
KFF
Regulation Number
864.7525Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN DIAGNOSTICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ACTICHROME® Heparin (anti-fila) is a chromogenic assay intended for the quantitative determination of therapeutic heparin in human plasma by measurement of factor IIa (thrombin) inhibition. The Electra 900C® was used to determine performance data. This kit is for in vitro diagnostic use.
Device Description
ACTICHROME® Heparin (anti-fIIa) Product No. 820
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K Number
K013492Device Name
IMUBIND TPA ELISA, MODEL 860
Manufacturer
AMERICAN DIAGNOSTICA, INC.
Date Cleared
2002-03-13
(142 days)
Product Code
GGP
Regulation Number
864.7290Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN DIAGNOSTICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IMUBIND® tPA ELISA is an enzyme-linked immunosorbent assay for the measurement of human tissue-type Plasminogen Activator (tPA) antigen in plasma. This kit is for in vitro diagnostic use. Levels of tPA in plasma are known to be elevated in late stage pregnancy, myocardial infarction, atherosclerosis, and stroke.
Device Description
IMUBIND® tPA ELISA is an enzyme-linked immunosorbent assay for the measurement of human tissue-type Plasminogen Activator (tPA) antigen in plasma.
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K Number
K013318Device Name
ACTICHROME HEPARIN (ANTI-FXA), MODEL 832
Manufacturer
AMERICAN DIAGNOSTICA, INC.
Date Cleared
2002-03-08
(154 days)
Product Code
KFF
Regulation Number
864.7525Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN DIAGNOSTICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ACTICHROME® Heparin (anti-fXa) is a chromogenic assay intended for the quantitative determination of unfractionated and low molecular weight heparins in human plasma. The assay measures the inhibition of factor Xa (fXa) activity by the various heparins. The Electra 900C® was used to determine performance data. This kit is for in vitro diagnostic use.
Device Description
ACTICHROME® Heparin (anti-fXa) is a chromogenic assay intended for the quantitative determination of unfractionated and low molecular weight heparins in human plasma. The assay measures the inhibition of factor Xa (fXa) activity by the various heparins.
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K Number
K013168Device Name
IMUBIND PLASMA PAI-1 ELISA,MODEL 822
Manufacturer
AMERICAN DIAGNOSTICA, INC.
Date Cleared
2002-03-07
(167 days)
Product Code
GGP
Regulation Number
864.7290Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN DIAGNOSTICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IMUBIND® Plasma PAI-1 ELISA is an enzyme-linked immunosorbent assay for the measurement of Plasminogen Activator Inhibitor Type-1 (PAI-1) antigen in human plasma. This kit is for in vitro diagnostic use. High levels of PAI-1 antigen are known to be associated with deep vein thrombosis and myocardial infarction.
Device Description
The IMUBIND® Plasma PAI-1 ELISA is an enzyme-linked immunosorbent assay for the measurement of Plasminogen Activator Inhibitor Type-1 (PAI-1) antigen in human plasma. All plate wells contain antibody to PAI-1.
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K Number
K012386Device Name
ACTICLOT PROTEIN S, MODEL 843L
Manufacturer
AMERICAN DIAGNOSTICA, INC.
Date Cleared
2001-09-14
(49 days)
Product Code
GGP
Regulation Number
864.7290Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN DIAGNOSTICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ACTICLOT® Protein S clotting assay is an in vitro diagnostic device intended for the quantitative determination of Protein S activity in human plasma.
Protein S activity levels in plasma are known to be low in patients with congenital Protein S deficiencies type-I, type-IIb, and type-IIb, and may also be low in pregnant I fotom & donemelers with liver disease and in inflammatory disease in which levels of C4b wonline in patients with are elevated. A decrease in Protein S activity is associated with an increased incidence of thromboembolism.
Device Description
ACTICLOT Protein S is an in vitro diagnostic clotting assay for the quantitative determination of Protein S activity in human plasma.
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