Panels › Microbiology › Product code OYP · Class 2
Anti-Jcv Antibody Detection Assay
Regulation 866.3336
0510(k)s in 12 months (2 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OYP
| Company | 510(k)s | Recalls |
|---|---|---|
| Focus Diagnostics, Inc. | 2 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2015 | Focus Diagnostics Inc STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic. Terminated |
OYP | K120986 |
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