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

Corgenix submits 510(k) filing for antibody test kit:

This article was originally published in Clinica

Executive Summary

Corgenix Medical, of Denver, Colorado, has submitted a 510(k) marketing application to the US FDA for its IgG anti-AtherOx test kit. The application seeks to allow the use of the test in patients with systemic lupus erythematosus (SLE) and lupus-like disorders such as antiphospholipid syndrome, to assess their risk of vascular injuries or thrombosis. The laboratory test uses the firm's AtherOx technology to detect IgG antibodies against complexes formed by oxidised low-density lipoprotein with beta2-glycoprotein I.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT049327

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