Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

HCV guidance

This article was originally published in The Gray Sheet

Executive Summary

Comments are due to the agency by Jan. 6, 2000 on recently released draft guidance on premarket approval applications for assays for diagnosis or monitoring of hepatitis C that would allow use of unapproved HCV-RNA assays as corroborating evidence, as long as supporting information is provided

You may also be interested in...



Abbott AxSYM HCV Test Needs Confirmation; Panel Recommends Approval

Positive test results with Abbott's AxSYM hepatitis C virus (HCV) microparticle enzyme immunoassay (MEIA) should be verified with a specific or supplemental test before being reported to the patient, FDA's Microbiology Devices Panel recommended at its Jan. 21 meeting in Rockville, Maryland.

E.l.f. Has A Go At Twitch Crowd, Hitching Wagon To #Loserfruit

The maker of prestige-inspired cosmetics at value prices follows its TikTok viral success by teaming with Kathleen Belsten, aka Loserfruit, the second most-followed female gamer on the Amazon-owned livestreaming platform Twitch.

UsernamePublicRestriction

Register

LL1134786

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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