PMA P130027S004
- Device
- artus CMV RGQ MDx Kit and artus CMV QS-RGQ MDx Kit
- Applicant
- Qiagen, Inc.
- PMA number
- P130027
- Supplement
- S004
- Product code
- PAB
- Decision date
- 2018-03-13
- Classification
- Cytomegalovirus (cmv) Dna Quantitative Assay
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- Approval for relocation of a manufacturing process.
Current openFDA PMA Record#
- Device
- artus CMV RGQ MDx Kit and artus CMV QS-RGQ MDx Kit
- Applicant
- Qiagen, Inc.
- PMA number
- P130027
- Supplement
- S004
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2018-03-13
- Decision code
- APPR
- Date received
- 2017-07-28
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for relocation of a manufacturing process.