PMA P130027S002
- Device
- ARTUS CMV RGQ MDX KIT
- Applicant
- Qiagen, Inc.
- PMA number
- P130027
- Supplement
- S002
- Product code
- PAB
- Decision date
- 2017-06-02
- Classification
- Cytomegalovirus (cmv) Dna Quantitative Assay
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- 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.
Current openFDA PMA Record#
- Device
- ARTUS CMV RGQ MDX KIT
- Applicant
- Qiagen, Inc.
- PMA number
- P130027
- Supplement
- S002
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2017-06-02
- Decision code
- APPR
- Date received
- 2016-11-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- 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.