Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | INFORM HER2 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 | S018 |
Date Received | 05/01/2014 |
Decision Date | 07/30/2014 |
Product Code |
NYQ |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE EXTENSION OF STABILITY DATING FOR THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL SYSTEM, WHICH INCLUDES THE FOLLOWING PRODUCTS: INFORM HER2 DUAL ISH DNA PROBE COCKTAIL, ULTRAVIEW RED ISH DIG DETECTION KIT, ULTRAVIEW SISH DNP DETECTION KIT. |
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