OMG · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3980
Classification
FDA Product Code
OMG
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3980
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.