NYQ · Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
· Class 3
Overview
| Product Code | NYQ |
|---|---|
| Device Name | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer |
| Device Class | Class 3 |
| Review Panel |
Identification
This device is intended to detect her2 gene amplification in formalin-fixed, paraffin-embedded breast carcinoma tissue sections using chromogenic in situ hybridization and brightfield microscopy. Indicated as an aid in the assessment of patients for whom herceptin. (trastuzumab) treatment is being considered. Interpretation of test results must be made within the context of the patients clinical history by a qualified pathologist.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P190031 | HER2 Dual ISH DNA Probe Cocktail | Ventana Medical Systems, Inc. | Jul 28, 2020 | APPR |
| P100024 | HER2 CISH PHARMDX KIT | Dako Denmark A/S | Nov 30, 2011 | APWD |
| P100027 | INFORM HER2 DUAL ISH DNA PROBE COCKTAIL | Ventana Medical Systems, Inc. | Jun 14, 2011 | APWD |
| P050040 | SPOT-LIGHT HER2 CISH KIT | Invitrogen Corporation | Jul 1, 2008 | APWD |
Top Applicants
- Ventana Medical Systems, Inc. — 2 clearances
- Dako Denmark A/S — 1 clearance
- Invitrogen Corporation — 1 clearance
