Majority Of IHCs Deemed Class I, 510(k)-Exempt in June 3 Final Rule
This article was originally published in The Gray Sheet
Low-risk immunohistochemical stains used as adjuncts to a conventional histopathologic diagnostic examination are classified as Class I and 510(k)-exempt by FDA's June 3 final rule on the in vitro devices.
You may also be interested in...
Abbott is launching a second test to detect COVID-19. The diagnostics giant announced on 27 March the release of a rapid, point-of-care test that can deliver results within five minutes.
President Trump on 27 March finally pulled the trigger on using his powers under the Defense Production Act, forcing General Motors Co. to manufacture medical ventilators. The only thing is, GM is already doing that.
Theradaptive's “paint-like” regenerative therapeutic can be applied to any device to promote bone regrowth or regenerate tissue.