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.
| Device | ARTUS CMV RGQ MDX KIT |
| Classification Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Generic Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Applicant | QIAGEN, INC. |
| Date Received | 2013-12-05 |
| Decision Date | 2014-06-02 |
| Notice Date | 2014-06-30 |
| PMA | P130027 |
| Supplement | S |
| Product Code | PAB |
| Docket Number | 14M-0866 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | QIAGEN, INC. qaigen Strasse 1 40724 hilden 40724 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P130027 | | Original Filing |
| S006 |
2018-08-30 |
30-day Notice |
| S005 |
2018-03-08 |
30-day Notice |
| S004 |
2017-07-28 |
135 Review Track For 30-day Notice |
| S003 |
2017-06-29 |
Normal 180 Day Track |
| S002 |
2016-11-14 |
Normal 180 Day Track |
| S001 |
2015-06-12 |
30-day Notice |
NIH GUDID Devices