Aptima HCV Quant Dx Assay

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

FDA Premarket Approval P160023 S009

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 an alternate cleaning method for the samples racks used on the panther, panther fusion, and tigris instruments.

DeviceAptima HCV Quant Dx Assay
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
ApplicantHOLOGIC, INC.
Date Received2018-12-31
Decision Date2019-02-28
PMAP160023
SupplementS009
Product CodeMZP
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address HOLOGIC, INC. 10210 Genetic Center Dr san Diego, CA 92121

Supplemental Filings

Supplement NumberDateSupplement Type
P160023Original Filing
S019 2020-07-09 30-day Notice
S018
S017 2020-02-12 30-day Notice
S016 2019-12-23 Real-time Process
S015 2019-06-21 Normal 180 Day Track
S014 2019-05-21 30-day Notice
S013 2019-04-19 30-day Notice
S012 2019-03-27 30-day Notice
S011 2019-03-18 Real-time Process
S010 2019-02-21 30-day Notice
S009 2018-12-31 Real-time Process
S008 2018-11-29 30-day Notice
S007 2018-10-03 30-day Notice
S006 2018-08-31 30-day Notice
S005 2018-07-09 30-day Notice
S004 2018-05-09 135 Review Track For 30-day Notice
S003 2018-04-20 30-day Notice
S002 2018-03-12 30-day Notice
S001 2017-08-28 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
15420045506800 P160023 000
15420045506794 P160023 000
15420045506787 P160023 000

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