OMG

Antisera, Fluorescent, Human Metapneumovirus

Product code

OMG

Device name

Antisera, Fluorescent, Human Metapneumovirus

Device class

Class 2

21 CFR

21 CFR 866.3980

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification definition

It is intended for the qualitative detection and identification of human metapneumovirus (hMPV) in direct respiratory specimens or cell culture. The assay detects hMPV antigens by immunofluorescence using antibodies, from patients with signs and symptoms of acute respiratory infection. This assay detects but is not intended to differentiate the four recognized genetic sub-lineages of hMPV.

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