OEM · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3980
Classification
FDA Product Code
OEM
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
A qualitative in vitro diagnostic assay intended to detect human metapneumovirus (hmpv) rna extracted from human respiratory specimens or viral cultures. Detection of hmpv rna aids in the diagnosis of respiratory hmpv infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infections.