Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Device Classification Name inherited nucleotide repeat disorder dna test
De Novo Number DEN190023
Device Name AmplideX Fragile X Dx & Carrier Screen Kit
Requester
asuragen, inc.
2150 woodward, suite 100
austin,  TX  78744
Contact bernard andruss
Regulation Number866.5970
Classification Product Code
OYV  
Date Received04/18/2019
Decision Date 02/21/2020
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Molecular Genetics
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
-
-