FDA product code PSL

25-Oh-Vitamin D Mass Spectrometry Test System

Clinical Chemistry·Class 2·21 CFR 862.1840
US regulatory classifications
US Product Code (FDA)
PSL
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 862.1840
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Medical specialty
Clinical Chemistry
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A 25-OH-Vitamin D Mass Spectrometry test system is intended to for vitro diagnostic use in the quantitative determination of total 25-hydroxyvitamin D (25-OH-D)using mass spectrometry.

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25-Oh-Vitamin D Mass Spectrometry Test System 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.