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Found 79 results
510(k) Data Aggregation
K Number
K090920Device Name
HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
2009-12-30
(273 days)
Product Code
CFN
Regulation Number
866.5510Why did this record match?
Applicant Name (Manufacturer) :
THE BINDING SITE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K083289Device Name
HUMAN BETA-2 MICROGLOBULIN KIT
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
2009-05-06
(180 days)
Product Code
JZG
Regulation Number
866.5630Why did this record match?
Applicant Name (Manufacturer) :
THE BINDING SITE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K082129Device Name
HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
2009-02-10
(196 days)
Product Code
CFN, JIT, JJX
Regulation Number
866.5510Why did this record match?
Applicant Name (Manufacturer) :
THE BINDING SITE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This kit is intended for the quantitative in vitro determination of human IgM in human serum, heparinised or EDTA plasma, using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Device Description
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K Number
K081827Device Name
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
2008-12-19
(175 days)
Product Code
CFN
Regulation Number
866.5510Why did this record match?
Applicant Name (Manufacturer) :
THE BINDING SITE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This kit is intended for the quantitative in vitro determination of human IgA in serum, lithium heparin or EDTA plasma, using the Binding Site SPAPIJS turbidimetric analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.
Device Description
Human IgA liquid reagent kit for use on SPAPLUS™
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K Number
K081674Device Name
BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
2008-10-15
(120 days)
Product Code
MST
Regulation Number
866.5750Why did this record match?
Applicant Name (Manufacturer) :
THE BINDING SITE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These assays are designed for the in-vitro measurement of specific IgG or IgA antibodies against a modified gliadin peptide (MGP) in human serum, as an aid in the diagnosis of coeliac disease in conjunction with other clinical and laboratory findings.
Device Description
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K Number
K080384Device Name
HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
2008-06-06
(114 days)
Product Code
NDY
Regulation Number
862.1225Why did this record match?
Applicant Name (Manufacturer) :
THE BINDING SITE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Cystatin C kit is intended for the quantitative determination of Cystatin C in human serum, lithium heparin, plasma and EDTA plasma by turbidimetry using the Roche Modular P analyser. Cystatin C measurements in serum and plasma are used as an aid in the diagnosis and treatment of renal diseases in conjunction with other laboratory and clinical findings.
Device Description
Human Cystatin C kit For Use on the Modular P
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K Number
K072889Device Name
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
2008-02-01
(114 days)
Product Code
CFN
Regulation Number
866.5510Why did this record match?
Applicant Name (Manufacturer) :
THE BINDING SITE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K070900Device Name
FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
2007-11-30
(242 days)
Product Code
DFH, DEH
Regulation Number
866.5550Why did this record match?
Applicant Name (Manufacturer) :
THE BINDING SITE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the quantitation of kappa free light chains in serum on the Roche COBAS INTEGRA 400 and 400plus. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings.
For the quantitation of lambda free light chains in serum on the Roche COBAS INTEGRA 400 and 400plus. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings.
Device Description
Not Found
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K Number
K062372Device Name
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
2007-06-21
(311 days)
Product Code
DFH, DEH
Regulation Number
866.5550Why did this record match?
Applicant Name (Manufacturer) :
THE BINDING SITE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This kit is intended for the quantitation of kappa free light chains in serum on The Binding Site SpaPlus. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings.
This kit is intended for the quantitation of lambda free light chains in serum on The Binding Site SpaPlus. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings.
Device Description
Not Found
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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?
Applicant Name (Manufacturer) :
THE BINDING SITE, LTD.
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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