OYV — Inherited Nucleotide Repeat Disorder Dna Test Class II
FDA product code OYV covers "Inherited Nucleotide Repeat Disorder Dna Test", a Class II medical device regulated under 21 CFR 866.5970. Submissions are reviewed by the Immunology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OYV
- Device Class
- Class II
- Regulation Number
- 866.5970
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Immunology
- Implant
- No
Definition
An inherited nucleotide repeat disorder DNA test is a prescription in vitro diagnostic test that is intended to detect and identify the number of nucleotide repeats in a gene using genomic DNA isolated from post-natal patient specimens. It is solely intended as an aid for carrier testing and as an aid for the diagnosis of inherited nucleotide repeat-associated disorders. Assay results are solely intended to be used in conjunction with other clinical and diagnostic findings. These tests do not include those indicated for use for fetal diagnostic testing or newborn screening.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN190023 | asuragen | AmplideX Fragile X Dx & Carrier Screen Kit | February 21, 2020 |