artus CMV RGQ MDx Kit and artus CMV QS-RGO MDx Kit

Cytomegalovirus (cmv) Dna Quantitative Assay

FDA Premarket Approval P130027 S006

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Modify the bulk manufacturing process and qc testing for an assay control reagent.

• Device: artus CMV RGQ MDx Kit and artus CMV QS-RGO MDx Kit
• Classification Name: Cytomegalovirus (cmv) Dna Quantitative Assay
• Generic Name: Cytomegalovirus (cmv) Dna Quantitative Assay
• Applicant: QIAGEN, INC.
• Date Received: 2018-08-30
• Decision Date: 2018-09-26
• PMA: P130027
• Supplement: S006
• Product Code: PAB
• Advisory Committee: Microbiology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: QIAGEN, INC. qaigen Strasse 1 40724 hilden 40724

Supplemental Filings

Supplement Number	Date	Supplement Type
P130027		Original Filing
S006	2018-08-30	30-day Notice
S005	2018-03-08	30-day Notice
S004	2017-07-28	135 Review Track For 30-day Notice
S003	2017-06-29	Normal 180 Day Track
S002	2016-11-14	Normal 180 Day Track
S001	2015-06-12	30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
04053228024538	P130027	000
04053228002086	P130027	000