Weburine, and also to determine the albumin-to-creatinine ratio in urine. The strip results are read on the analyzer. J. Substantial Equivalence Information: 1. Predicate device name(s): Instrument: Clinitek Status Analyzer Assay: Clinitek Microalbumin 2 Reagent Strips read on Clinitek Status Analyzer . Controls: Biorad Liquicheck Urinalysis ... Web• The CLINITEK STATUS and CLINITEK 50 Analyzers are CLIA waived ... Note: Package insert for use with the products listed below. STORAGE: ... Sensitivity: 15–30 mg/dL albumin Performance characteristics:The protein test pad is not specific for a particular protein, and proteins other than albumin can cause a positive ...
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION …
WebLiquid, made with human urine. 1-month open vial stability at room temperature for maximum portability*. 18-month shelf life & open vial stability from date of manufacture when stored at 2ºC–8ºC*. Our Dropper Plus POC Urinalysis Dipstick Control eliminates storage problems and gives you maximum portability by providing one month of room ... WebThe CLINITEK Microalbumin 2 Reagent Strips are ready to use upon removal from the bottle and the reagent strip is disposable. The strips are read instrumentally, using the … darmmedizin
Siemens Clinitek User manual - ManualMachine.com
WebDescription. Unit: 25/box Regulatory Status: CLIA Waived / Professional Use Only Contents: 25 Microalbumin Test strips, Package insert For Use With: CLINITEK Status ® + Analyzer Storage Requirements: 18 to 30ºC … WebCLINITEK Status+ Analyzer - Small, point of care, CLIA-waived, semi-automated urine analyzer can perform up to four types of urine tests: Traditional urine strips, albumin-to … Webmicroalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests such as Acetest, ® Clinitest, and Ictotest® reagent tablets, and for hCG methods. Product Description The Quantimetrix Dropper Urine Dipstick Controls are supplied in two levels, 2 x 25 mL each level per box. mark cottrell obituary