Alinity m HCV

FDA Premarket Approval P190025 S002

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

Manufacturing change to increase the fill volume of activation reagent in the alinity m hcv act tray 2.

DeviceAlinity m HCV
Generic NameAssay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
ApplicantAbbott Molecular, Inc.
Date Received2020-05-07
Decision Date2020-06-09
PMAP190025
SupplementS002
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
S002 2020-05-07 30-day Notice
S001 2020-04-06 30-day Notice

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