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.
| Device Type ID | 672 |
| Device Name | 25-oh-vitamin D Mass Spectrometry Test System |
| Physical State | Mass Spectrometer, Liquid Chromatography-tandem Mass Spectrometer |
| Technical Method | Liquid Chromatography-tandem Mass Spectrometry (LC-MS/MS), Mass Spectrometry |
| Target Area | In Vitro Diagnostic Use |
| Regulation Description | Total 25-hydroxyvitamin D Mass Spectrometry Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.1840 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PSL |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |