FDA product code PYP
Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test
Clinical Chemistry·Class 1·21 CFR 862.1475
US regulatory classifications
- US Product Code (FDA)
- PYPView Product Code Classification →
- US Risk Class (FDA)
- Class 1
- US Regulation (CFR)
- 21 CFR 862.1475View CFR Regulation →
- Medical specialty
- Clinical Chemistry
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
Definition
For the quantitative determination of low-density lipoprotein (LDL) cholesterol sub-fractions.
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About this record
Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test is a medical device type in the Clinical Chemistry specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.