OYVClass II

Inherited Nucleotide Repeat Disorder Dna Test

21 CFR 866.5970 / Immunology

OYV is the FDA product code for Inherited Nucleotide Repeat Disorder Dna Test, a class II device type, regulated under 21 CFR 866.5970. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2020-02-21, and no recalls.

Classification record

Product code: OYV
Device name: Inherited Nucleotide Repeat Disorder Dna Test
FDA 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.
Regulation: 21 CFR 866.5970
Device class: Class II
Review panel: Immunology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code OYV

By decision year

1 clearance under product code OYV with a decision year between 2020 and 2020, 2020 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code OYV by decision year
Year	Clearances
2020	1

Applicants with the most clearances

Product code OYV

Applicants holding the most 510(k) clearances under product code OYV
Applicant	Clearances
Asuragen, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Asuragen, Inc.

Recent clearances

Product code OYV

DEN190023Class IIAmplideX Fragile X Dx & Carrier Screen KitAsuragen, Inc. / cleared 2020-02-21

Recent recalls

Product code OYV

FDA records show no recalls under product code OYV.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)