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Fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucml I15809. htm for Page 2-Dr. Bleile the Center for Devices and Radiological Health s CDRI- s Office of Compliance. Also please note the regulation entitled Misbranding by reference to premarket notification 2ICFR Part 807. Bleile Ph. D. Re k130200 Trade/Device Name Piccolo Regulation Number 21 CER 862. 1175 Regulatory Class 1 meets limitations of exemptions per 21 CFR 862. Page 4 TableS3 Within-Run and Total Precision of Total Cholesterol...
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What is piccolo total cholesterol?
Piccolo total cholesterol is a blood test that measures the total amount of cholesterol in your blood.
Who is required to file piccolo total cholesterol?
Individuals may be required to have piccolo total cholesterol test based on their health condition or risk factors.
How to fill out piccolo total cholesterol?
To fill out piccolo total cholesterol, you will need to have blood drawn by a healthcare professional and the results will be provided to you.
What is the purpose of piccolo total cholesterol?
The purpose of piccolo total cholesterol test is to assess your risk for heart disease and other health conditions related to high cholesterol levels.
What information must be reported on piccolo total cholesterol?
The report will include your total cholesterol levels, as well as levels of HDL (good) cholesterol, LDL (bad) cholesterol, and triglycerides.
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