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510(k) Data Aggregation
K Number
K063744Device Name
COBAS INTEGRA C 111
Manufacturer
ROCHDIAG
Date Cleared
2007-01-17
(30 days)
Product Code
CIG
Regulation Number
862.1110Why did this record match?
Applicant Name (Manufacturer) :
ROCHDIAG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
In vitro test for the quantitative determination of total bilirubin in human serum and plasma on the cobas c 111 system.
Measurements of the levels of bilirubin and organic compound formed during normal and abnormal destruction of red cells, is used in the diagnosis of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder block.
Device Description
The Total Bilirubin Special reagent is intended for use on the cobas c 111 analyzer for the quantitative determination of total or direct bilirubin in serum and plasma.
The cobas c 111 analyzer is a partially automated, in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride.
The cobas c 111 instrument is a random access analyzer designed to be operated on a bench top in the professional environment using a combination of a photometric analysis unit and an optional ion selective electrodes (ISE).
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K Number
K011658Device Name
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS
Manufacturer
ROCHDIAG
Date Cleared
2001-07-31
(63 days)
Product Code
JIX
Regulation Number
862.1150Why did this record match?
Applicant Name (Manufacturer) :
ROCHDIAG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in the calibration of Roche lipid methods on automated clinical chemistry analyzers.
Device Description
The Calibrator for Automated Systems (C.f.a.s.) consists of liquid human serum with biological materials added as required to obtain desired component levels. Values for constituent analytes are provided in product labeling.
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K Number
K010978Device Name
TINA-QUANT ALPHA-1 ANTITRYPSIN
Manufacturer
ROCHDIAG
Date Cleared
2001-05-18
(66 days)
Product Code
DEM
Regulation Number
866.5130Why did this record match?
Applicant Name (Manufacturer) :
ROCHDIAG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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