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510(k) Data Aggregation
K Number
K992274Device Name
MODIFICATION TO IMX HOMOCYSTEINE
Manufacturer
AXIS BIOCHEMICALS, ASA
Date Cleared
1999-10-06
(92 days)
Product Code
LPS
Regulation Number
862.1377Why did this record match?
Applicant Name (Manufacturer) :
AXIS BIOCHEMICALS, ASA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IMx® Homocysteine assay is a Fluorescence Polarization Immunoassay (FPIA) for the quantitative measurement of total Lhomocysteine in human serum or plasma on the IMx Analyzer. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Device Description
IMx Homocysteine is a Fluorescence Polarization Immunoassay for the quantitative measurement of total L-homocysteine in human serum or plasma on the IMx Analyzer.
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K Number
K980907Device Name
AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY
Manufacturer
AXIS BIOCHEMICALS, ASA
Date Cleared
1998-10-16
(220 days)
Product Code
LPS, DFC, JJX
Regulation Number
862.1377Why did this record match?
Applicant Name (Manufacturer) :
AXIS BIOCHEMICALS, ASA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Axis Homocysteine Enzyme Immunoassay is intended for the quantitative measurement of total L-homocysteine in human serum or plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocysteinuria.
Device Description
The Axis Homocysteine Enzyme Immunoassay is designed for the quantitative determination of total homocysteine in plasma or serum. In the Axis Homocysteine Enzyme Immunoassay, protein bound homocysteine is reduced to free homocysteine, enzymatically converted to S-adenosyl-L-homocysteine (SAH), and detected in competitive immunoassay with monoclonal anti-SAH antibody.
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K Number
K980812Device Name
IMX HOMOCYSTEINE
Manufacturer
AXIS BIOCHEMICALS, ASA
Date Cleared
1998-10-01
(212 days)
Product Code
DFC, LPS
Regulation Number
866.5600Why did this record match?
Applicant Name (Manufacturer) :
AXIS BIOCHEMICALS, ASA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IMx Homocysteine assay is a Fluorescence Polarization Immunoassay (FPIA) for the quantitative measurement of total L-homocysteine in human serum or plasma on the IMx Analyzer. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Device Description
IMx Homocysteine is a Fluorescence Polarization Immunoassay for the quantitative measurement of total L-homocysteine in human serum or plasma on the IMx Analyzer. IMx Homocysteine is calibrated with IMx Homocysteine Calibrators. IMx Homocysteine Controls are assayed for the verification of the accuracy and precision of the Abbott IMx Analyzer.
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