Device |
chemiluminescent immunoassay system |
Definition |
For in vitro diagnostic use in the quantitative measurement of hyaluronic acid in human serum. |
Physical State |
n/a |
Technical Method |
Chemiluminescent immunoassay |
Target Area |
In vitro |
Review Panel |
Toxicology |
Product Code | PKM |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Chemistry and Toxicology Devices
(DCTD)
|
Not Classified Reason
|
For Export Only
|
Submission Type |
Contact ODE
|
Device Class |
Not Classified
|
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 |