Medtech Insight is part of the Business Intelligence Division 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

Tuberculosis (TB) blood culture tests will require FDA clearance

This article was originally published in Clinica

Executive Summary

Automated blood culturing systems used in disease diagnosis must obtain US premarket notification clearance from October 25th, 1995. The FDA says it is revoking the exemption from 510(k) requirements for these devices because of significant questions of safety and effectiveness. It cites the reported failure of devices used in detecting Mycobacterium tuberculosis.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT092669

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