Aptima HPV Assay

Kit, Rna Detection, Human Papillomavirus

FDA Premarket Approval P100042 S025

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

To remove or modify qc testing for reagent labels

DeviceAptima HPV Assay
Classification NameKit, Rna Detection, Human Papillomavirus
Generic NameKit, Rna Detection, Human Papillomavirus
ApplicantGEN-PROBE INCORPORATED
Date Received2019-08-02
Decision Date2019-08-27
PMAP100042
SupplementS025
Product CodeOYB
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address GEN-PROBE INCORPORATED 10210 Genetic Center Drive san Diego, CA 92121

Supplemental Filings

Supplement NumberDateSupplement Type
P100042Original Filing
S033 2022-01-19 30-day Notice
S032
S031 2020-07-09 30-day Notice
S030 2020-05-14 30-day Notice
S029 2020-02-03 30-day Notice
S028 2019-12-23 Real-time Process
S027
S026 2019-08-21 30-day Notice
S025 2019-08-02 30-day Notice
S024
S023 2019-03-27 30-day Notice
S022 2019-03-18 Real-time Process
S021 2019-02-21 30-day Notice
S020 2018-12-31 Real-time Process
S019 2018-08-31 30-day Notice
S018 2018-08-16 30-day Notice
S017 2018-03-15 30-day Notice
S016 2018-02-08 30-day Notice
S015 2017-12-20 30-day Notice
S014 2017-10-10 30-day Notice
S013 2017-09-01 Normal 180 Day Track
S012 2017-03-17 Real-time Process
S011 2016-08-15 30-day Notice
S010 2016-04-25 30-day Notice
S009 2015-10-16 30-day Notice
S008 2015-08-28 135 Review Track For 30-day Notice
S007 2015-08-12 Normal 180 Day Track
S006
S005 2015-03-04 30-day Notice
S004 2014-12-24 Normal 180 Day Track No User Fee
S003 2014-06-09 30-day Notice
S002 2014-04-17 Real-time Process
S001 2012-10-04 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
15420045500105 P100042 001
15420045500099 P100042 001
15420045500082 P100042 001
15420045500075 P100042 001
15420045500068 P100042 001
15420045500051 P100042 001

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