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Found 4 results
510(k) Data Aggregation
K Number
K981786Device Name
IGA MININEPH ANTISERUM
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
1999-11-24
(553 days)
Product Code
CFQ
Regulation Number
866.5510Why did this record match?
Product Code :
CFQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This assay is designed for the in vitro measurement of human IgA in serum using the MININEPH analyzer.
Device Description
Not Found
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K Number
K990551Device Name
IGG FLEX REAGENT CARTRIDGE
Manufacturer
DADE BEHRING, INC.
Date Cleared
1999-03-25
(31 days)
Product Code
CFQ, CFO
Regulation Number
866.5510Why did this record match?
Product Code :
CFQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IGG Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure immunoglobulin G (IgG) in serum and plasma.
Device Description
The IGG Flex™ reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay based on the precipitation of IgG by its polyclonal antibodies.a IgG from serum or plasma reacts with its polyclonal antibodies to form an immunoprecipitate. Addition of polyethylene glycol accelerates the formation of the precipitate. Turbidity created by immunoprecipitation is measured as bichromatic endpoint measurements at 340 and 700 nm. The increase in turbidity is proportional to the concentration of IgG and it is calculated from a five point calibration curve.
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K Number
K990552Device Name
IMMUNOGLOBULIN A TEST SYSTEM
Manufacturer
DADE BEHRING, INC.
Date Cleared
1999-03-25
(31 days)
Product Code
CFQ
Regulation Number
866.5510Why did this record match?
Product Code :
CFQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IGA Flex™ reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic device intended to quantitatively measure immunoglobulin A in serum and plasma.
Device Description
The IGA Flex™ reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay based on the precipitation of IgA by its polyclonal antibodies.a
IgA from serum or plasma reacts with its polyclonal antibodies to form an immunoprecipitate. Addition of polyethylene glycol accelerates the formation of the precipitate. Turbidity created by immunoprecipitation is measured as bichromatic endpoint measurements at 340 and 700 um. The increase in turbidity is proportional to the concentration of IgA and it is calculated from a five point calibration curve.
PEG IgA + Antibody ------------------------> IgA-Antibody Complex
a The antibody is manufactured by Dade Behring, Marburg, Germany
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K Number
K990553Device Name
IGM FLEX REAGENT CARTRIDGE
Manufacturer
DADE BEHRING, INC.
Date Cleared
1999-03-22
(28 days)
Product Code
CFQ
Regulation Number
866.5510Why did this record match?
Product Code :
CFQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IGM Flex™ reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic test intended to quantitatively measure immunoglobulin M (IgM) in serum and plasma.
Device Description
The IGM Flex™ reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay based on the precipitation of IgM by its polyclonal antibodies. IgM from serum or plasma reacts with its polyclonal antibodies to form an immunoprecipitate. Addition of polyethylene glycol accelerates the formation of the precipitate. Turbidity created by immunoprecipitation is measured as bichromatic endpoint measurements at 340 and 700 nm. The increase in turbidity is proportional to the concentration of IgM and it is calculated from a five point calibration curve.
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