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510(k) Data Aggregation
K Number
K141100Device Name
OPTILITE C1 INACTIVATOR KIT
Manufacturer
THE BINDING SITE GROUP LTD
Date Cleared
2014-07-18
(80 days)
Product Code
DBA
Regulation Number
866.5250Why did this record match?
Product Code :
DBA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Optilite Cl Inactivator Kit is intended for the quantitative in vitro measurement of human C1 Inactivator in human serum using the Binding Site Optilite analyser. Measurement of CI inactivator levels in serum is an aid in the diagnosis of hereditary angioedema (HAE) in conjunction with other laboratory and clinical findings.
Device Description
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K Number
K122304Device Name
HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS
Manufacturer
THE BINDING SITE GROUP, LTD.
Date Cleared
2013-04-15
(257 days)
Product Code
DBA
Regulation Number
866.5250Why did this record match?
Product Code :
DBA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Human C1 Inactivator kit for use on SPAPLUS is intended for the in vitro measurement of human C1 inactivator in human serum using the SPAPLUS Analyzer. Measurement of C1 inactivator levels in serum is an aid in the diagnosis of hereditary angioedema (HAE) in conjunction with other laboratory and clinical findings.
Device Description
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K Number
K072965Device Name
DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON
Manufacturer
DADE BEHRING, INC.
Date Cleared
2007-12-21
(60 days)
Product Code
DBA, JIT, JJX
Regulation Number
866.5250Why did this record match?
Product Code :
DBA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dimension Vista® C1IN Flex® reagent cartridge: The C1IN method is an in vitro diagnostic test for the quantitative measurement of C1 inhibitor in human serum and plasma on the Dimension Vista® System. Measurements of C1 Inhibitor aid in the diagnosis of hereditary angioneurotic edema (increase blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).
Dimension Vista® C1IN CAL: The C1IN CAL is an in vitro diagnostic product for the calibration of the C1 Inhibitor (C1IN) method on the Dimension Vista® System.
Dimension Vista® C1IN CON: C1 Inhibitor Control is an assayed, mid level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of C1 Inhibitor (C1IN).
Device Description
Dimension Vista® C1IN Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista® C1IN CAL: C1 Calibrator is a lyophilized, human plasma based product containing C1 Inhibitor (C1IN).
Dimension Vista® C1IN CON: C1 Control is a lyophilized, mid-level, human plasma based products containing C1 Inhibitor (C1IN).
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K Number
K011780Device Name
K-ASSAY C1-INA
Manufacturer
KAMIYA BIOMEDICAL CO.
Date Cleared
2001-07-25
(48 days)
Product Code
DBA
Regulation Number
866.5250Why did this record match?
Product Code :
DBA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The K-ASSAY C1-INA Assay is intended for the quantitative determination of human Complement-1 Inactivators in human plasma by immunoturbidimetric assay for hereditary angioedema. FOR IN VITRO DIAGNOSTIC USE.
Device Description
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K Number
K003747Device Name
C1-INHIBITOR MICROTITER ASSAY DEVICE
Manufacturer
BAXTER HEALTHCARE CORP.
Date Cleared
2001-03-19
(105 days)
Product Code
DBA
Regulation Number
866.5250Why did this record match?
Product Code :
DBA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K965024Device Name
N-ASSAY TIA C1-INACTIVATOR TEST KIT
Manufacturer
CRESTAT DIAGNOSTICS, INC.
Date Cleared
1997-07-14
(209 days)
Product Code
DBA
Regulation Number
866.5250Why did this record match?
Product Code :
DBA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The N-Assay TIA C1 Inactivator Test Kit is intended to be used for the quantification of Cl Inactivator in human plasma. Cl Inactivator is measured by immunoturbidimetric assay. Measurement of Complement I Inhibitor aids in the diagnosis of hereditary angioneurotic edema and a rare form of angioedema associated with lymphoma.
Device Description
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K Number
K960257Device Name
N ANTISERUM TO C1 INHIBITOR
Manufacturer
BEHRING DIAGNOSTICS, INC.
Date Cleared
1996-08-01
(196 days)
Product Code
DBA
Regulation Number
866.5250Why did this record match?
Product Code :
DBA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
In vitro diagnostic reagent for the quantitative determination of C1-inactivator, C1-esterase inhibitor) in human plasma and serum with the Behring Nephelometers. Measurement of C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).
Device Description
In vitro diagnostic reagent for the quantitative determination of C1-inactivator, C1-esterase inhibitor) in human plasma and serum with the Behring Nephelometers. Measurement of C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of anqioedema associated with lymphoma (lymph node cancer).
In an immunochemical reaction, C1 Inhibitor in the human plasma sample form immune complexes with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
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