Approval to expand the use of the artus cmv rgq mdx assay system to include the qiasymphony rgq mdx system. The new assay system includes the qiasymphony sp instrument and qiasymphony dsp virus/pathogen kit for automated sample preparation, automated assay setup on the qiasymphony as, artus cmv qs rgq mdx kit, and rotor-gene q mdx instrument with rotor-gene assaymanager v1. 0 software.
| 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 | 2016-11-14 |
| Decision Date | 2017-06-02 |
| PMA | P130027 |
| Supplement | S002 |
| Product Code | PAB |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | QIAGEN, INC. qaigen Strasse 1 40724 hilden 40724 |
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