Search Results
Found 2 results
510(k) Data Aggregation
K Number
K081875Device Name
GENTIAN CYSTATIN C IMMUNOASSAY
Manufacturer
Date Cleared
2008-08-20
(49 days)
Product Code
Regulation Number
862.1225Why did this record match?
Applicant Name (Manufacturer) :
GENTIAN AS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Gentian Cystatin C Immunoassay is an in-vitro diagnostic test for quantitative determination of cystatin c in human serum and plasma. The measurement of cystatin c is used in the diagnosis and treatment of renal diseases.
The instruments that can be used with the assay are: The Beckman Coulter™ Synchron® and UniCel® Systems
Device Description
The Gentian cystatin C Immunoassay is a particle enhanced turbidimetric immunoassay (PETIA). The immunoparticles are made from activated polystyrene microspheres to which avian anti-human cystatin C antibodies are covalently attached. The immunoparticles and cystatin C form aggregations that change the absorbance signal, depending on the amount of cystatin C present. Measurements obtained by this device are used for the determination of Cystatin C in human serum and plasma. The Gentian cystatin C assay is calibrated with human Cystatin C calibrators. Cystatin C controls are assayed for the verification of the accuracy and precision of the Gentian cystatin C immunoassay.
Ask a Question
Ask a specific question about this device
K Number
K071388Device Name
GENTIAN CYSTATIN C IMMUNOASSAY
Manufacturer
Date Cleared
2007-11-06
(172 days)
Product Code
Regulation Number
862.1225Why did this record match?
Applicant Name (Manufacturer) :
GENTIAN AS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Gentian Cystatin C Immunoassay is an in-vitro diagnostic test for quantitative determination of cystatin c in human serum and plasma. The measurement of cystatin c is used in the diagnosis and treatment of renal diseases.
Device Description
The Gentian cystatin C immunoassay is a particle enhanced turbidimetric immunoassay (PETIA). The immunoparticles are made from activated polystyrene microspheres to which avian anti-human cystatin C antibodies are covalently attached. The immunoparticles and cystatin C form aggregations that change the absorbance signal, depending on the amount of cystatin C present. Measurements obtained by this device are used for the determination of Cystatin C in human serum and plasma. The Gentian C assay is calibrated with human Cystatin C calibrators. Cystatin C controls are assayed for the verification of the accuracy and precision of the Gentian cystatin C immunoassay.
Ask a Question
Ask a specific question about this device
Page 1 of 1