DeviceClearance

Product code OMG— Microbiology

D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT

Classification name
Antisera, Fluorescent, Human Metapneumovirus
Device class
Class 2
Regulation
21 CFR 866.3980
Advisory panel
Microbiology
Total cleared
4
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OMG under 21 CFR 866.3980, via openFDA

Market context for product code OMG

FDA has cleared 4 devices under product code OMG between 2009 and 2010, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OMG

Recent clearances under product code OMG

Data sourced from openFDA. This site is unofficial and independent of the FDA.