PSL
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- 25-Oh-Vitamin D Mass Spectrometry Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1840
- Medical specialty
- Clinical Chemistry
- FDA 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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| Record | Firm | Date |
|---|---|---|
| Vitamin D 200M Assay for the Topaz System (DEN170019) | Ab Sciex, LLC | 2017-05-18 |
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