OYV

Inherited Nucleotide Repeat Disorder Dna Test

Product code

OYV

Device name

Inherited Nucleotide Repeat Disorder Dna Test

Device class

Class 2

21 CFR

21 CFR 866.5970

Medical specialty

Immunology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).