| Device |
multiplex flow immunoassay, t. gondii, rubella and cmv |
| Regulation Description |
Rubella virus serological reagents. |
| Definition |
The kit is a multiplex immunoassay intended for the quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondii) and Rubella, and qualitative detection of Cytomegalovirus (CMV) IgG in human serum and/ or plasma. Indicated as an aid in the determination of serological status to T. gondii, Rubella and CMV. This kit is not intended for use in screening blood or plasma donors. |
| Physical State |
The device is a fully automated instrument. |
| Technical Method |
The device utilizes multiplex immunofluorescence technology to assess the presence of IgG antibodies for each of the analytes in the panel in a single sample by binding to antigen-coated fluoromagnetic beads with unique fluorescent signatures. |
| Target Area |
Assay |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | OMI |
|---|
| Premarket Review |
Division of Microbiology Devices
(DMD)
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 |
