QJR

Reagents, 2019-Novel Coronavirus Nucleic Acid

Product code: QJR
Device name: Reagents, 2019-Novel Coronavirus Nucleic Acid
Device class: Class N
Medical specialty: Unknown
Marketing pathway: EUA - Emergency Use Authorization

FDA classification definition

Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QJR

Classification and pathway per current FDA publications. Data from openFDA (CC0).