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U.S. Department of Health and Human Services

Product Classification

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Device low-density lipoprotein (ldl) cholesterol sub-fraction test
Regulation Description Lipoprotein test system.
Definition For the quantitative determination of low-density lipoprotein (LDL) cholesterol sub-fractions.
Physical State The assay uses surfactants and enzymes that react with certain groups of lipoproteins.
Technical Method Quantitative colorimetric assay
Target Area Human serum or plasma.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodePYP
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.1475
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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