Device |
multi-analyte respiratory virus antigen detection test |
Definition |
A multi-analyte respiratory virus antigen detection test is an in vitro diagnostic device intended for the detection and/or differentiation of respiratory viruses directly from respiratory clinical specimens. The device is intended to be performed at the site of sample collection, does not involve sample storage and/or transport. |
Physical State |
Solid Phase Test Device/Dip-Stick |
Technical Method |
Multi-Analyte Lateral Flow Immunochromatographic Assay |
Target Area |
Respiratory Clinical Specimens |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | SCA |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.3987
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |