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Found 17 results
510(k) Data Aggregation
K Number
K101319Device Name
IMMULISA DSDNA ANTIBODY ELISA
Manufacturer
IMMCO DIAGNOSTICS, INC.
Date Cleared
2010-12-09
(212 days)
Product Code
LRM
Regulation Number
866.5100Why did this record match?
Product Code :
LRM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An enzyme linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG antibodies to double stranded DNA (dsDNA) in human serum, as an aid in the diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings.
Device Description
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K Number
K083381Device Name
EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)
Manufacturer
EUROIMMUN US INC
Date Cleared
2009-04-15
(152 days)
Product Code
LRM
Regulation Number
866.5100Why did this record match?
Product Code :
LRM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EUROIMMUN Anti-dsDNA-NcX ELISA (IgG) test kit is designed for the quantitative or qualitative determination of IgG class autoantibodies against double-stranded genomic DNA (dsDNA) in human serum and EDTA or citrate plasma. It is used as an aid in the diagnosis of systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.
Device Description
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K Number
K062183Device Name
FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
2006-11-21
(113 days)
Product Code
LRM
Regulation Number
866.5100Why did this record match?
Product Code :
LRM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This assay is intended for the in-vitro measurement of specific, high avidity IgG autoantibodies against double stranded deoxyribonucleic acid (dsDNA) present in human serum, as an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other serological test results and clinical findings.
Device Description
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K Number
K040811Device Name
VARELISA SSDNA ANTIBODIES, MODEL 14896
Manufacturer
PHARMACIA DEUTSCHLAND GMBH
Date Cleared
2004-05-13
(45 days)
Product Code
LRM
Regulation Number
866.5100Why did this record match?
Product Code :
LRM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Varelisa ssDNA Antibodies EIA kit is designed for the semiquantitative and qualitative determination of anti-single stranded DNA (ssDNA) autoantibodies in serum or plasma. In conjunction with the Varelisa dsDNA Antibodies kit it assists in the diagnosis of systemic lupus erythematosus (SLE) and certain other rheumatic diseases. The test is not definitive in isolation but has to be seen as one parameter in a multicriterion diagnostic process.
Device Description
Varelisa ssDNA Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of ssDNA antibodies in human serum or plasma. Antibodies specific for ssDNA present in the patient sample bind to the antigen. The assay should be used in combination with the Varelisa dsDNA Antibodies.
The test kit contains microplate strips coated with synthetic ssDNA, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, Sample Diluent and wash buffer.
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K Number
K001900Device Name
ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
Manufacturer
HELIX DIAGNOSTICS, INC.
Date Cleared
2000-09-11
(81 days)
Product Code
LRM
Regulation Number
866.5100Why did this record match?
Product Code :
LRM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000477Device Name
MDI DS-DNA TEST
Manufacturer
MICRO DETECT, INC.
Date Cleared
2000-03-01
(16 days)
Product Code
LRM
Regulation Number
866.5100Why did this record match?
Product Code :
LRM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994424Device Name
DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM
Manufacturer
DIAMEDIX CORP.
Date Cleared
2000-02-18
(50 days)
Product Code
LRM
Regulation Number
866.5100Why did this record match?
Product Code :
LRM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diamedix Is-anti-dsDNA an Enzyme Immunoassay (EIA) for the quantitative detection of IgG antibodies to double-stranded (ds) DNA in human serum as an aid in the diagnosis of systemic lupus erythematosus (SLE). These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.
Device Description
The Is-anti-dsDNA Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and quantitation of IgG antibodies to DNA in human serum.
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K Number
K993727Device Name
BINDAZYME ANTI-DSDNA EIA KIT
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
1999-12-21
(57 days)
Product Code
LRM
Regulation Number
866.5100Why did this record match?
Product Code :
LRM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This assay is intended for the in-vitro measurement of specific IgG autoantibodies against double stranded deoxyribonucleic acid (dsDNA) present in human serum, as an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other clinical findings.
Device Description
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K Number
K984396Device Name
LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213
Manufacturer
BIO-RAD
Date Cleared
1998-12-18
(9 days)
Product Code
LRM
Regulation Number
866.5100Why did this record match?
Product Code :
LRM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Liquichek Anti-dsDNA Control is intended for use as an unassayed quality control to monitor immunoassay procedures for the detection of dsDNA autoantibodies.
Device Description
Liquichek Anti-dsDNS Control is prepared from human serum with added preservatives and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.
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K Number
K983422Device Name
THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET
Manufacturer
ZEUS SCIENTIFIC, INC.
Date Cleared
1998-11-18
(50 days)
Product Code
LRM
Regulation Number
866.5100Why did this record match?
Product Code :
LRM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The presence of autoantibodies to a number of nuclear constituents has proven to be useful in the diagnosis of various connective tissue diseases. Although the exact etiology of autoimmune diseases is unknown, and the specific role played by autoantibodies in the onset of various autoimmune connective tissue diseases is obscure, the association and frequency of detection of these antibodies may play a key role in the diagnostic work-up of patients with suspected connective tissue diseases.
The dsDNA ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies dsDNA.
Device Description
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