AmplideX Fragile X Dx & Carrier Screen Kit

Inherited Nucleotide Repeat Disorder Dna Test

Asuragen, Inc.

The following data is part of a De Novo classification by Asuragen, Inc. with the FDA for Amplidex Fragile X Dx & Carrier Screen Kit.

Pre-market Notification Details

DeNovo IDDEN190023
Device Name:AmplideX Fragile X Dx & Carrier Screen Kit
ClassificationInherited Nucleotide Repeat Disorder Dna Test
Applicant Asuragen, Inc. 2150 Woodward, Suite 100 Austin,  TX  78744
ContactBernard Andruss
Product CodeOYV  
CFR Regulation Number866.5970 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardMolecular Genetics
Classification AdvisoryDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Fo
TypeDirect
Date Received2019-04-18
Decision Date2020-02-21
Reclassification Order:Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.