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510(k) Data Aggregation
K Number
K972706Device Name
CLINITEK MICROALBUMIN REAGENT STRIPS
Manufacturer
BAYER CORP.
Date Cleared
1997-09-09
(50 days)
Product Code
CJG, JFY
Regulation Number
862.1035Why did this record match?
Product Code :
CJG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CLINITEK Microalbumin Reagent Strips are firm plastic strips that contain two reagent areas to test for small amounts of albumin in urine (microalbuminuria) creatinine) in urine, and also determine the albumin-to-creatinine ratio in urine. The strips are read instrumentally using the CLINITEK® 50 or CLINITEK® 100 Urine Chemistry Analyzer and provide semi-quantitative results. CLINITEK Microalbumin Reagent Strips can be used for screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage. CLINITEK Microalbumin Reagent Strips are for professional use.
Device Description
CLINITEK® Microalbumin Reagent Strips are firm plastic strips that contain two reagent areas to test for microalbumin (low concentration of albumin) and creatinine in urine. CLINITEK Microalbumin Reagent Strips are dipped into a urine specimen and "read" instrumentally by the CLINITEK® 50 or CLINITEK® 100 Urine Chemistry Analyzer. In addition to providing an albumin and a creatinine result, an albumin-to-creatinine ratio is also determined. Semi-quantitative results are available within one minute.
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