• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 
Trade NameARTUS CMV RGQ MDX KIT
Classification Namecytomegalovirus (cmv) dna quantitative assay
ApplicantQIAGEN, INC.
PMA NumberP130027
Date Received12/05/2013
Decision Date06/02/2014
Product Code
PAB[ Registered Establishments with PAB ]
Docket Number 14M-0866
Notice Date 06/30/2014
Advisory Committee Microbiology
Clinical Trials NCT01034709
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the artus cmv rgq mdx kit. This device is indicated for: the artus cmv rgq mdx kit is an in vitro nucleic acid amplification test for the quantitation of human cytomegalovirus (cmv) dna in human edta plasma. The artus cmv rgq mdx kit is intended for use as an aid in the management of solid organ transplant patients who are undergoing anti-cmv therapy. The test measures cmv dna levels in edta plasma and can be used to assess cmv viral load response to antiviral drug therapy. The results from the artus cmv rgq mdx kit must be interpreted within the context of all relevant clinical and laboratory findings. The artus cmv rgq mdx kit is configured for use with the ez1 dsp virus system (ez1 dsp virus kit and ez1 advanced instruments) for dna extraction and the rotor-gene q mdx instrument for cmv dna amplification and quantitation. The artus cmv rgq mdx kit is not intended for use as a screening test for blood or blood products.
Approval Order Approval Order
-
-