Product code MVC ยท Class 3
System, Test, Her-2/Neu, Ihc
0510(k)s in 12 months (0 all time)
0recalls in 12 months (8 all time)
0recalls that name a 510(k)
Top companies in MVC
| Company | 510(k)s | Recalls |
|---|---|---|
| Biogenex Laboratories | 0 | 5 |
| Dakocytomation California Inc | 0 | 2 |
| Ventana Medical Systems Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2014 | Biogenex Laboratories, Inc. InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use. Terminated |
MVC | None listed |
| Mar 16, 2010 | Ventana Medical Systems Inc VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY
(PATHWAY HER2 (4B5)); Model Number: 790-2991, Lot number: 680957, in vitro diagnostic. Terminated |
MVC | None listed |
| Mar 15, 2006 | Biogenex Laboratories Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu Monoclonal Antibody, Automated;
Model number: AM134-10MP;
Lo Terminated |
MVC | None listed |
| Mar 15, 2006 | Biogenex Laboratories Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu Monoclonal Antibody, Manual;
Model number: AM134-5MP;
Lot Num Terminated |
MVC | None listed |
| Mar 15, 2006 | Biogenex Laboratories Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu IHC Kit, Automated;
Model Numbers: RD134-YAX;
Lot Numbers: RD Terminated |
MVC | None listed |
| Mar 15, 2006 | Biogenex Laboratories Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu IHC Kit, Manual;
Model Numbers: RD134-60K;
Lot Numbers: RD134 Terminated |
MVC | None listed |
| Nov 1, 2005 | Dakocytomation California Inc K 520711-2, Hercep Test, 35Test, HER2, Protein Terminated |
MVC | None listed |
| Nov 1, 2005 | Dakocytomation California Inc K 520411-2, Hercep Test, 35Test, HER2, Protein Terminated |
MVC | None listed |
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