Artus CMV RGQ and QS-RGQ MDx Kit

Cytomegalovirus (cmv) Dna Quantitative Assay

FDA Premarket Approval P130027 S003

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

Approval for a change to the enzyme in a component of the device.

DeviceArtus CMV RGQ and QS-RGQ MDx Kit
Classification NameCytomegalovirus (cmv) Dna Quantitative Assay
Generic NameCytomegalovirus (cmv) Dna Quantitative Assay
ApplicantQIAGEN, INC.
Date Received2017-06-29
Decision Date2017-11-15
PMAP130027
SupplementS003
Product CodePAB
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address QIAGEN, INC. qaigen Strasse 1 40724 hilden 40724

Supplemental Filings

Supplement NumberDateSupplement Type
P130027Original 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 IDPMASupp
04053228024538 P130027 000
04053228002086 P130027 000
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