Product code PYP
- Device name
- Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1475
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Definition
- For the quantitative determination of low-density lipoprotein (LDL) cholesterol sub-fractions.
- Source
- FDA openFDA device classification dataset