Definition: This Is A Qualitative DNA Detection In Vitro Diagnostic Test To Be Used In Conjunction With A Visualization Instrument And Its Software. This Test Is For The Simultaneous Detection And Identification Of Allelic Variants Found In The Alpha-1 Antitryps
| Device Type ID | 3109 |
| Device Name | Serpina1 Variant Detection System |
| Physical State | Qualitative In Vitro Molecular Diagnostic System Used To Detect Variants In SERPINA1 Gene In Genomic DNA Isolated From Human Specimens. The Accompanying Software Application Is Used To View And Analyze Genotype Data And Conducts A Variety Of Control |
| Technical Method | Qualitative In Vitro Molecular Diagnostic System Used To Detect Variants In SERPINA1 Gene In Genomic DNA Isolated From Human Specimens. The Results Of This Assessment System Are To Be Used In Conjunction With Clinical Findings And Other Laboratory Te |
| Target Area | Human Specimens |
| Regulation Description | Alpha-1-antitrypsin Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(k) |
| CFR Regulation Number | 866.5130 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PZH |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |