We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » Guidance on 510(k)s for HLA Test Kits Gives Tips on Trial Design, Samples
Guidance on 510(k)s for HLA Test Kits Gives Tips on Trial Design, Samples
Accuracy studies for molecular detection methods employed by human leukocyte antigen tests should cover all probes or primers included in the kit, a new FDA draft guidance says.