PMA P130027S003
- Device
- Artus CMV RGQ and QS-RGQ MDx Kit
- Applicant
- Qiagen, Inc.
- PMA number
- P130027
- Supplement
- S003
- Product code
- PAB
- Decision date
- 2017-11-15
- Classification
- Cytomegalovirus (cmv) Dna Quantitative Assay
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- Approval for a change to the enzyme in a component of the device.
Current openFDA PMA Record#
- Device
- Artus CMV RGQ and QS-RGQ MDx Kit
- Applicant
- Qiagen, Inc.
- PMA number
- P130027
- Supplement
- S003
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2017-11-15
- Decision code
- APPR
- Date received
- 2017-06-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change to the enzyme in a component of the device.