Device |
multiplex flow immunoassay, t. gondii, rubella, cmv igm |
Regulation Description |
Rubella virus serological reagents. |
Definition |
The kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma. |
Physical State |
In-vitro diagnostic kit. |
Technical Method |
The device utilizes multiplex fluorescence technology. |
Target Area |
Human serum / plasma |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | PUQ |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.3510
|
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 |
|
|