Definition: Dna Quality Control Material For Genetic Testing Is A Device Intended For Medical Purposes For Use In A Test System To Estimate Test Precision And To Detect Systematic Analytical Deviations That May Arise From Reagent Or Analytical Instrument Variati
| Device Type ID | 3113 |
| Device Name | Quality Control Material, Genetics, Dna |
| Physical State | This Type Of Device Includes Synthetic DNA Controls And Cell-line Based Controls. |
| Technical Method | No Method, Quality Control Material |
| Target Area | No Target Area, IVD |
| Regulation Description | Quality Control Material For Cystic Fibrosis Nucleic Acid Assays. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 866.5910 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NZB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |