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This document provides a summary of the 510(k) premarket notification for the ELiTech Clinical Systems CREATININE PAP SL device, which is intended for the in vitro diagnostic determination of creatinine
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How to fill out elitech clinical systems creatinine
How to fill out ELiTech Clinical Systems CREATININE PAP SL
01
Gather all necessary materials, including the ELiTech Clinical Systems CREATININE PAP SL kit and a blood sample.
02
Carefully read the instructions provided in the kit to understand the procedure.
03
Using the provided pipette, transfer the appropriate volume of blood sample to the designated reaction vessels.
04
Add the reagents provided in the kit according to the specified amounts and sequence.
05
Mix the contents gently to ensure proper reaction between the sample and reagents.
06
Incubate the mixture for the recommended time at the specified temperature.
07
Measure the resulting color change using a spectrophotometer or colorimetric reader.
08
Record the results following the kit's guidelines for data entry and interpretation.
Who needs ELiTech Clinical Systems CREATININE PAP SL?
01
Healthcare professionals and laboratories that conduct renal function tests.
02
Clinics and hospitals that require accurate measurement of creatinine levels in patients.
03
Patients being monitored for kidney function or potential renal impairment.
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People Also Ask about
What is creatinine clearance formula used for?
Creatinine Clearance Calculator Calculation information: This formula is applicable only if the serum creatinine is stable. Est. Creatinine Clearance = [[140 - age(yr)]*weight(kg)]/[72*serum Cr(mg/dL)] (multiply by 0.85 for women).
What is the ELITech glucose reagent?
ELITech Clinical Systems GLUCOSE PAP SL is an in vitro diagnostic reagent intended for the quantitative determination of glucose in human serum and plasma samples on analyzers or semi-automatic analyzers.
What is normal creatinine PAP?
Normal Results A normal result is 0.7 to 1.3 mg/dL (61.9 to 114.9 µmol/L) for men and 0.6 to 1.1 mg/dL (53 to 97.2 µmol/L) for women. Women often have a lower blood creatinine level than men. This is because women often have less muscle mass than men. Creatinine level varies based on a person's size and muscle mass.
What is the ELITech creatinine reagent?
ELITech Clinical Systems CREATININE JAFFE is an in vitro diagnostic reagent intended for the quantitative determination of creatinine in human serum samples on analyzers or semi-automatic analyzers.
What is the reagent used for creatinine?
There are two reagents used in this method with components and concentrations listed as following: Reagent 1(R1) : Sodium hydroxide 0.2 mol/l, Reagent 2 (R2) : Picric acid 20 mmol/l. Mix four parts of R1 and one part of R2 to form a monoreagent. The stability of monoreagent: 5 hr at 15–25 °C.
What is the Jaffe reagent for creatinine?
Buffered Kinetic jaffé reaction without deproteinization. Creatinine reacts with picric acid under alkaline condition to form a yellow-red complex. The absorbance of the color produced, measured at a wavelength 492 nm, is directly proportional to creatinine concentration in the sample.
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What is ELiTech Clinical Systems CREATININE PAP SL?
ELiTech Clinical Systems CREATININE PAP SL is a form used for reporting creatinine levels in clinical settings, helping healthcare providers assess kidney function in patients.
Who is required to file ELiTech Clinical Systems CREATININE PAP SL?
Medical professionals, such as physicians or laboratory technicians, who conduct tests and report creatinine levels for patient assessments are required to file the ELiTech Clinical Systems CREATININE PAP SL.
How to fill out ELiTech Clinical Systems CREATININE PAP SL?
To fill out the ELiTech Clinical Systems CREATININE PAP SL, one must provide the patient's identification details, the test results, the date of the test, and any additional required clinical information as requested.
What is the purpose of ELiTech Clinical Systems CREATININE PAP SL?
The purpose of ELiTech Clinical Systems CREATININE PAP SL is to standardize the reporting of creatinine levels, facilitating better communication and decision-making in patient care related to kidney function.
What information must be reported on ELiTech Clinical Systems CREATININE PAP SL?
The information that must be reported on the ELiTech Clinical Systems CREATININE PAP SL includes patient name, date of birth, date of test, creatinine measurement results, and clinician's details.
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