|
Device | INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL |
Generic Name | Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer |
Applicant | VENTANA MEDICAL SYSTEMS, INC. 1910 E. Innovation Park Dr. Tucson, AZ 85755 |
PMA Number | P100027 |
Supplement Number | S011 |
Date Received | 09/12/2013 |
Decision Date | 10/10/2013 |
Product Code |
NYQ |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement ADDITION OF A NEW SUPPLIER OF TWO BIOCONJUGATES FOR THE ULTRAVIEW SISH DNP DETECTION KIT AND THE ULTRAVIEW RED ISH DIG DETECTION KIT. BOTH DETECTION KITS ARE PARTS OF THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL. |