The following data is part of a De Novo classification by Asuragen, Inc. with the FDA for Amplidex Fragile X Dx & Carrier Screen Kit.
| DeNovo ID | DEN190023 |
| Device Name: | AmplideX Fragile X Dx & Carrier Screen Kit |
| Classification | Inherited Nucleotide Repeat Disorder Dna Test |
| Applicant | Asuragen, Inc. 2150 Woodward, Suite 100 Austin, TX 78744 |
| Contact | Bernard Andruss |
| Product Code | OYV |
| CFR Regulation Number | 866.5970 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device 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 Board | Molecular Genetics |
| Classification Advisory | Device 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 |
| Type | Direct |
| Date Received | 2019-04-18 |
| Decision Date | 2020-02-21 |
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863840000254 | DEN190023 | 000 |