Trinucleotide Repeat Disorder Dna Test
Device Code: 3141
Product Code(s):
OYV Definition: The Trinucleotide Repeat Disorder Dna Test Is An In Vitro Diagnostic Device Intended To Amplify And Detect The Presence Of Specific Triplet Nucleotide Repeats To Aid In The Diagnosis Of Genetic Inherited Disorders Associated With Mental Retardation O
Device Classification Information
| Device Type ID | 3141 |
| Device Name | Trinucleotide Repeat Disorder Dna Test |
| Physical State | Gene Region Specific Amplification Test System. Should Not Include Products Not Intended For Export Only Or For Products Intended For Re-importation Into The USA |
| Technical Method | Uses Polymerase Chain Reaction (PCR) And Amplicon Fragment Sizing On A DNA Genetic Analyzer Or Capillary Electrophoresis Platform To Determine The Number Of Triplet Repeats. |
| Target Area | Peripheral Human Whole Blood Or Human Tissue. |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | Contact ODE |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | OYV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3141 |
| Device | Trinucleotide Repeat Disorder Dna Test |
| Product Code | OYV |
TPLC Last Update: 2019-04-02 20:24:30