Alinity m HCV

FDA Premarket Approval P190025 S005

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

Addition of alternative testing location for a device component

DeviceAlinity m HCV
Generic NameAssay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
ApplicantAbbott Molecular, Inc.
Date Received2021-02-05
Decision Date2021-03-05
PMAP190025
SupplementS005
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Molecular, Inc. 1300 E. Touhy Avenue des Plaines, IL 60018

Supplemental Filings

Supplement NumberDateSupplement Type
P190025Original Filing
S006 2021-04-15 Real-time Process
S005 2021-02-05 30-day Notice
S004
S003 2020-12-21 30-day Notice
S002 2020-05-07 30-day Notice
S001 2020-04-06 30-day Notice

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.