Device |
enzyme linked immunoabsorbent assay, cytomegalovirus |
Regulation Description |
Cytomegalovirus serological reagents. |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | LFZ |
Premarket Review |
Center for Biologics Evaluation & Research (CBER)
|
Submission Type |
510(k)
|
Regulation Number |
866.3175
|
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 |
|
|