Device |
adalimumab assay |
Definition |
An in vitro diagnostic device intended for the measurement of adalimumab, an anti-tumor necrosis factor alpha monoclonal antibody |
Physical State |
Solid, dry reagent pack liquid reagents and liquid control solutions |
Technical Method |
Time-resolved fluorescence energy transfer immunoassay |
Target Area |
Serum |
Regulation Medical Specialty |
Toxicology |
Review Panel |
Toxicology |
Product Code | QYD |
Premarket Review |
Division of Chemistry and Toxicology Devices
(DCTD)
Division of Chemistry and Toxicology Devices
(DCTD)
|
Submission Type |
510(k)
|
Regulation Number |
862.3115
|
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 |
|
|