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Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test

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.

Global Registration Data
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Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test
Clinical Chemistry Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

PYP

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Class 1

21 CFR 862.1475

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Clinical Chemistry

Device Characteristics

No

No

No

Eligible

Definition

For the quantitative determination of low-density lipoprotein (LDL) cholesterol sub-fractions.