COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0

Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus

FDA Premarket Approval P060030 S081

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

Change of a supplier's manufacturing site for critical components

DeviceCOBAS AmpliPrep/COBAS TaqMan HCV Test v2.0
Classification NameAssay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
Generic NameAssay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
ApplicantRoche Molecular Systems, Inc.
Date Received2019-10-08
Decision Date2019-11-05
PMAP060030
SupplementS081
Product CodeMZP
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588-2722

Supplemental Filings

Supplement NumberDateSupplement Type
P060030Original Filing
S081 2019-10-08 30-day Notice
S080 2019-09-20 30-day Notice
S079 2019-08-16 30-day Notice
S078 2019-07-15 Special (immediate Track)
S077 2019-05-23 Real-time Process
S076 2019-04-24 30-day Notice
S075 2019-04-10 30-day Notice
S074 2019-04-08 30-day Notice
S073 2019-03-20 30-day Notice
S072 2018-12-14 30-day Notice
S071 2018-11-13 30-day Notice
S070 2018-11-09 30-day Notice
S069 2018-08-21 30-day Notice
S068 2018-07-27 30-day Notice
S067 2018-06-29 30-day Notice
S066 2018-06-08 30-day Notice
S065 2018-06-04 30-day Notice
S064 2018-04-16 30-day Notice
S063 2018-04-16 30-day Notice
S062 2018-03-01 30-day Notice
S061 2017-11-14 30-day Notice
S060 2017-09-26 30-day Notice
S059 2017-08-07 30-day Notice
S058 2017-07-14 30-day Notice
S057 2017-07-14 30-day Notice
S056 2017-04-21 Special (immediate Track)
S055 2016-09-22 30-day Notice
S054 2016-08-16 30-day Notice
S053 2016-07-19 30-day Notice
S052 2016-07-08 30-day Notice
S051 2016-04-18 30-day Notice
S050 2016-04-07 30-day Notice
S049 2015-11-17 Real-time Process
S048 2015-08-31 Normal 180 Day Track
S047 2015-04-09 30-day Notice
S046 2015-03-13 30-day Notice
S045 2015-02-25 Real-time Process
S044 2014-12-19 30-day Notice
S043 2014-07-28 30-day Notice
S042 2014-03-31 30-day Notice
S041 2014-03-18 30-day Notice
S040 2014-02-18 30-day Notice
S039 2014-02-03 30-day Notice
S038 2013-12-13 30-day Notice
S037 2013-09-09 30-day Notice
S036 2013-09-09 30-day Notice
S035 2013-08-14 30-day Notice
S034 2013-08-09 30-day Notice
S033 2013-07-26 30-day Notice
S032 2013-05-09 30-day Notice
S031 2012-11-16 Real-time Process
S030 2012-11-06 Real-time Process
S029 2012-09-13 30-day Notice
S028 2012-08-15 30-day Notice
S027 2012-07-02 Normal 180 Day Track
S026 2012-05-30 Real-time Process
S025 2012-03-29 Normal 180 Day Track No User Fee
S024 2011-12-12 135 Review Track For 30-day Notice
S023 2011-09-12 30-day Notice
S022 2011-08-24 30-day Notice
S021 2011-07-01 Normal 180 Day Track
S020 2011-05-31 Normal 180 Day Track No User Fee
S019
S018 2011-04-07 Special (immediate Track)
S017 2011-03-01 30-day Notice
S016 2011-03-01 135 Review Track For 30-day Notice
S015 2011-02-08 30-day Notice
S014 2010-08-25 30-day Notice
S013
S012 2010-08-05 30-day Notice
S011
S010 2010-05-03 30-day Notice
S009 2010-03-01 30-day Notice
S008 2010-01-08 30-day Notice
S007 2009-12-24 30-day Notice
S006 2009-12-22 Normal 180 Day Track
S005 2009-09-15 30-day Notice
S004 2009-07-02 30-day Notice
S003 2009-04-28 30-day Notice
S002 2008-12-05 30-day Notice
S001 2008-11-14 30-day Notice

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