PMA P130027
- Device
- artus CMV RGQ MDx Kit and artus CMV QS-RGO MDx Kit
- Applicant
- Qiagen, Inc.
- PMA number
- P130027
- Supplement
- S006
- Product code
- PAB
- Decision date
- 2018-09-26
- Classification
- Cytomegalovirus (cmv) Dna Quantitative Assay
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- Modify the bulk manufacturing process and QC testing for an assay control reagent.
Current openFDA PMA Record#
- Device
- artus CMV RGQ MDx Kit and artus CMV QS-RGO MDx Kit
- Applicant
- Qiagen, Inc.
- PMA number
- P130027
- Supplement
- S006
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2018-09-26
- Decision code
- OK30
- Date received
- 2018-08-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the bulk manufacturing process and QC testing for an assay control reagent.