Device |
alpha-1-antitrypsin kit, qualitative phenotype |
Regulation Description |
Alpha-1-antitrypsin immunological test system. |
Definition |
The alpha-1-antitrypsin qualitative phenotype test result is used as an aid in the diagnosis of alpha-1-antitrypsin deficiency in conjunction with clinical and other laboratory findings. For in vitro diagnostic use only. |
Physical State |
A1AT Antibody Isoelectric focusing gel qualitative phenotype kit and A1AT qualitative phenotype control |
Technical Method |
Isoelectric focusing gel qualitative test. |
Target Area |
Blood serum |
Regulation Medical Specialty |
Immunology |
Review Panel |
Immunology |
Product Code | OBZ |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Immunology and Hematology Devices
(DIHD)
|
Submission Type |
510(k)
|
Regulation Number |
866.5130
|
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
|
Accredited Persons
|