Device |
anti-jcv antibody detection assay |
Definition |
The anti-jcv antibody detection assay is intended for the detection of antibodies to the john cunningham virus (jcv) in serum or plasma samples from multiple sclerosis (ms) and crohn's disease (cd) patients receiving immunomodulatory therapies. |
Physical State |
Reagent kit. |
Technical Method |
A serological test for the detection of the presence on anti-JCV specific antibodies in serum or plasma samples by an enzyme linked immunosorbent technology |
Target Area |
In-vitro diagnostic test |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | OYP |
Premarket Review |
Division of Microbiology Devices
(DMD)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.3336
|
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 |