PMA P130027S001
- Device
- ARTUS CMV RGQ MDX KIT
- Applicant
- Qiagen, Inc.
- PMA number
- P130027
- Supplement
- S001
- Product code
- PAB
- Decision date
- 2015-07-09
- Classification
- Cytomegalovirus (cmv) Dna Quantitative Assay
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- CHANGE TO THE SUPPLIER OF THE POSITIVE MATERIALS USED IN THE ARTUS CMV RGQ MDX KIT.
Current openFDA PMA Record#
- Device
- ARTUS CMV RGQ MDX KIT
- Applicant
- Qiagen, Inc.
- PMA number
- P130027
- Supplement
- S001
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2015-07-09
- Decision code
- OK30
- Date received
- 2015-06-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE SUPPLIER OF THE POSITIVE MATERIALS USED IN THE ARTUS CMV RGQ MDX KIT.