QTU

Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests

Product code: QTU
Device name: Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests
Device class: Class N
Medical specialty: Unknown
Marketing pathway: Enforcement Discretion

FDA classification definition

Antigen-based in vitro diagnostic devices for the detection of non-variola Orthopoxvirus or monkeypox virus and/or diagnosis of Monkeypox in human clinical specimens-EXPORT ONLY

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

Official FDA classification page: QTU

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