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 Code | OMG |
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 Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |