Product code OYV— Immunology
AmplideX Fragile X Dx & Carrier Screen Kit
- Classification name
- Inherited Nucleotide Repeat Disorder Dna Test
- Device class
- Class 2
- Regulation
- 21 CFR 866.5970
- Advisory panel
- Immunology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code OYV
FDA has cleared device under product code OYV, all in 2020, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code OYV
Recent clearances under product code OYV
Data sourced from openFDA. This site is unofficial and independent of the FDA.