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Device | PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY |
Generic Name | SYSTEM, TEST, HER-2/NEU, IHC |
Applicant | VENTANA MEDICAL SYSTEMS, INC. 1910 E. Innovation Park Dr. Tucson, AZ 85755 |
PMA Number | P990081 |
Supplement Number | S020 |
Date Received | 05/07/2013 |
Decision Date | 10/25/2013 |
Product Code |
MVC |
Advisory Committee |
Pathology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR ADDITION OF A NEW SUPPLIER OF BIOCONJUGATES FOR THE ULTRAVIEW UNIVERSAL DAB DETECTION KIT. THE DETECTION KIT IS PART OF THE PATHWAY ANTI-HER 2/NEU RABBIT MONOCLONAL PRIMARY ANTIBODY (4B5). |