• 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 nucleic acid amplification test for the quantitation of epstein-barr virus (ebv) dna
De Novo Number DEN200015
Device Name cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
Requester
Roche Molecular Systems, Inc.
4300 hacienda drive
pleasanton,  CA  94588 -2722
Contact rita hoady
Regulation Number866.3183
Classification Product Code
QLX  
Date Received03/02/2020
Decision Date 07/30/2020
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
Type Direct
-
-