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Found 8 results
510(k) Data Aggregation
K Number
K050967Device Name
VARELISA RECOMBI CTD SCREEN, MODEL 13096
Manufacturer
SWEDEN DIAGNOSTICS (GERMANY) GMBH
Date Cleared
2005-06-28
(71 days)
Product Code
LJM
Regulation Number
866.5100Why did this record match?
Applicant Name (Manufacturer) :
SWEDEN DIAGNOSTICS (GERMANY) GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Varelisa ReCombi CTD Screen EIA kit is designed for the qualitative determination of ten antinuclear antibodies in human serum or plasma to aid in the diagnosis of systemic rheumatic diseases such as SLE (systemic lupus erythematosus), drug-induced lupus, scleroderma (progressive systemic sclerosis), MCTD (mixed connective tissue disease), SS (Sjögren's syndrome) and polymyositis/dermatomyositis. The Varelisa ReCombi CTD Screen detects antibodies against dsDNA, RNP (RNP70,A,C), Sm (B,B',D), SS-A/Ro(52 kDa,60 kDa), SS-B/La, Scl-70, CENP-B, Histone, Ribosomal P Protein and Jo-1 in a single microwell.
Device Description
The new device is an enzyme-linked immunosorbent assay (ELISA) using microtiter plates as the solid phase. The plate wells are coated with antinuclear antigens, which allow anti-nuclear antibodies (sample) to react with the immobilized antigens. The conjugate is rabbit anti-human IgG horseradish peroxidase (HRP), which uses 3, 3'5, 5' tetramethylbenzidine dihydrochloride (TMB) as substrate. The kit contains calibrator and negative control. The kit also contains sample diluent, wash buffer concentrate and stop solution.
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K Number
K050625Device Name
VARELISA RECOMBI ANA PROFILE, MODEL 18496
Manufacturer
SWEDEN DIAGNOSTICS (GERMANY) GMBH
Date Cleared
2005-04-26
(46 days)
Product Code
LJM
Regulation Number
866.5100Why did this record match?
Applicant Name (Manufacturer) :
SWEDEN DIAGNOSTICS (GERMANY) GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Varelisa ReCombi ANA Profile EIA kit is designed for the qualitative determination of eight antinuclear antibodies in human serum or plasma to aid in the diagnosis of SLE (systemic lupus erythematosus), scleroderma (progressive systemic sclerosis and CREST syndrome), MCTD (mixed connective tissue disease), SS (Sjögren's syndrome) and polymyositis/dermatomyositis. The Varelisa ReCombi ANA Profile individually detects antibodies against dsDNA, U1 RNP (RNP 70 kDa,A,C), SmD, SS-A/Ro(52 kDa, 60 kDa), SS-B/La, Scl-70, CENP-B and Jo-1.
Device Description
The new device is an enzyme-linked immunosorbent assay (ELISA) using microtiter plates as the solid phase. Plate wells each coated with 1 of 8 different ANA antigens are included to allow corresponding antibodies in the patient samples react with the immobilized antigens. The conjugate is rabbit anti-human IgG horseradish peroxidase (HRP), which uses 3, 3'5, 5' tetramethylbenzidine dihydrochloride (TMB) as substrate. The kit contains a calibrator and a negative control. The kit also contains sample diluent, wash buffer concentrate and stop solution.
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K Number
K042629Device Name
VARELISA SM ANTIBODIES, MODEL 18296
Manufacturer
SWEDEN DIAGNOSTICS (GERMANY) GMBH
Date Cleared
2004-12-08
(72 days)
Product Code
LKP
Regulation Number
866.5100Why did this record match?
Applicant Name (Manufacturer) :
SWEDEN DIAGNOSTICS (GERMANY) GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Varelisa Sm Antibodies EIA kit is designed for the semiquantitative and qualitative determination of SmD antibodies in serum or plasma to aid in the diagnosis of systemic lupus erythematosus (SLE).
Device Description
The new device is an enzyme-linked immunosorbent assay (ELISA) using microtiter plates as the solid phase. The plate wells are coated with a synthetic SmD peptide as antigen, which allow anti-SmD antibodies to react with the immobilized antigen (sample). The conjugate is rabbit anti-human IgG horseradish peroxidase (HRP), which uses 3, 3'5, 5' tetramethylbenzidine dihydrochloride (TMB) as substrate. The kit contains a set of six calibrators, positive and negative controls. The kit also contains sample diluent, wash buffer concentrate and stop solution.
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K Number
K041173Device Name
CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996
Manufacturer
SWEDEN DIAGNOSTICS (GERMANY) GMBH
Date Cleared
2004-08-02
(89 days)
Product Code
MVM
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
SWEDEN DIAGNOSTICS (GERMANY) GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Celikey IgG is intended for the semiquantitative and qualitative measurement of anti-tissue transglutaminase (tTG) IgG antibodies in human serum and plasma. Celikey IgG is based on recombinant human tissue transglutaminase as antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease.
Device Description
Celikey IgG is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of tTG (IgG) antibodies in human serum or plasma. Antibodies specific for tTG present in the patient sample bind to the antigen.
The test kit contains microplate strips coated with purified recombinant human tTG antigen, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, sample diluent and wash buffer.
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K Number
K041357Device Name
VARELISA GLIADIN IGG ANTIBODIES
Manufacturer
SWEDEN DIAGNOSTICS (GERMANY) GMBH
Date Cleared
2004-08-02
(74 days)
Product Code
MST
Regulation Number
866.5750Why did this record match?
Applicant Name (Manufacturer) :
SWEDEN DIAGNOSTICS (GERMANY) GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Varelisa Gliadin IgG Antibodies EIA kit is designed for the semiquantitative and qualitative determination of gliadin (IgG) antibodies in serum or plasma to aid in the diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis.
Device Description
Varelisa Gliadin IgG Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of gliadin (IgG) antibodies in human serum or plasma. Antibodies specific for gliadin (IgG) present in the patient sample bind to the antigen.
The test kit contains microplate strips coated with gliadin antigen, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, sample diluent and wash buffer.
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K Number
K041174Device Name
CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196
Manufacturer
SWEDEN DIAGNOSTICS (GERMANY) GMBH
Date Cleared
2004-07-19
(75 days)
Product Code
MVM
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
SWEDEN DIAGNOSTICS (GERMANY) GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Celikey is intended for the semiquantitative and qualitative measurement of anti-tissue transglutaminase (tTG) IgA antibodies in human serum and plasma. Celikey is based on recombinant human tissue transglutaminase as antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease.
Device Description
Celikey is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of IgA antibodies against Tissue transglutaminase in human serum or plasma.
The test kit contains microplate strips coated with purified human recombinant tTG antigen, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, sample diluent and wash buffer.
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K Number
K041354Device Name
VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896
Manufacturer
SWEDEN DIAGNOSTICS (GERMANY) GMBH
Date Cleared
2004-07-16
(57 days)
Product Code
MST
Regulation Number
866.5750Why did this record match?
Applicant Name (Manufacturer) :
SWEDEN DIAGNOSTICS (GERMANY) GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Varelisa Gliadin IgA Antibodies EIA kit is designed for the semiquantitative and qualitative determination of gliadin (IgA) antibodies in serum or plasma to aid in the diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis.
Device Description
Varelisa Gliadin IgA Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of gliadin (IgA) antibodies in human serum or plasma. Antibodies specific for gliadin (IgA) present in the patient sample bind to the antigen. The test kit contains microplate strips coated with gliadin antigen, calibrators, test and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, sample diluent and wash buffer.
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K Number
K041040Device Name
VARELISA MPO ANCA, MODEL 17648/17696
Manufacturer
SWEDEN DIAGNOSTICS (GERMANY) GMBH
Date Cleared
2004-06-16
(55 days)
Product Code
MOB
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
SWEDEN DIAGNOSTICS (GERMANY) GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Varelisa MPO ANCA EIA kit is designed for the semi-quantitative and qualitative determination of myeloperoxidase anti neutrophil cytoplasmatic antibodies (MPO ANCA) in human serum or plasma to aid in the diagnosis of certain autoimmune vasculitides such as microscopic polyangiitis, and crescentic glomerulonephritis.
Device Description
Varelisa MPO ANCA is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of MPO ANCA in human serum or plasma. Antibodies specific for MPO present in the patient sample bind to the antigen.
The test kit contains microplate strips coated with human purified MPO ANCA antigen, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, Sample Diluent and wash buffer.
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