FDA product code OYV: Inherited Nucleotide Repeat Disorder Dna Test

OYV is the FDA product code for inherited nucleotide repeat disorder dna test. It is a Class II device, regulated under 21 CFR 866.5970 and reviewed by the Pathology panel. Devices under OYV reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

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.

Classification

Recalls for OYV devices

openFDA lists no recalls for product code OYV.

Frequently asked questions

What is FDA product code OYV?

OYV is the FDA product code for inherited nucleotide repeat disorder dna test. It is a Class II device, regulated under 21 CFR 866.5970 and reviewed by the Pathology panel.

What device class is OYV?

Class II, regulation 21 CFR 866.5970. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code OYV
• Run a recall and safety report across every OYV manufacturer
• Watch product code OYV for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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