Anti-jcv Antibody Detection Assay
Device Code: 3544
Product Code(s):
OYP 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.
Device Classification Information
| Device Type ID | 3544 |
| Device Name | Anti-jcv Antibody Detection Assay |
| 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 Description | John Cunningham Virus Serological Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3336 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OYP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3544 |
| Device | Anti-jcv Antibody Detection Assay |
| Product Code | OYP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | John Cunningham Virus Serological Reagents. |
| CFR Regulation Number | 866.3336 [🔎] |
| Device Problems |
|---|
False Positive Result | 1 |
| Total Device Problems | 1 |
| Recalls |
|---|
| Manufacturer | Recall Class | Date Posted |
| 1 | Focus Diagnostics Inc | II | Apr-17-2015 |
TPLC Last Update: 2019-04-02 20:32:05