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U.S. Department of Health and Human Services

Product Classification

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Device antisera, fluorescent, human metapneumovirus
Regulation Description Respiratory viral panel multiplex nucleic acid assay.
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.
Physical State hMPV DSFA, hMPV DFA
Technical Method The assay detects hMPV antigens by immunofluorescence using antibodies.
Target Area Direct clinical speciemns or cell culture amplified speciemns
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOMG
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3980
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible