Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Hep C Tests Down-Classified By FDA

The IVDs, now moderate-risk class II, had been high-risk class III

Executive Summary

Nucleic acid-based hepatitis C virus (HCV) ribonucleic acid tests and HCV antibody tests were reclassified as moderate-risk class II by the US FDA on 19 November. The agency says the change could spur competition among makers of in vitro diagnostics.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT144745

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel