DAKO TOP2A FISH PHARMDX KIT
FDA premarket approval P050045 · decided 2008-01-11
Approval details
- PMA number
- P050045
- Trade name
- DAKO TOP2A FISH PHARMDX KIT
- Generic name
- Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
- Applicant
- Dako Denmark A/S
- Date received
- 2005-11-30
- Decision date
- 2008-01-11
- Days to decision
- 772 days
- Decision code
- APWD
- Product code
- NXG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Glostrup
- Statement
- APPROVAL FOR THE TOP2A FISH PHARMDX KIT. THE DEVICE IS INDICATED FOR: TOP2A FISH PHARMDX KIT IS DESIGNED TO DETECT AMPLIFICATIONS AND DELETIONS (COPY NUMBER CHANGES) OF THE TOP2A GENE USING FLUORESCENCE IN SITU HYBRIDIZATION (FISH) TECHNIQUE ON FORMALIN-FIXED, PARAFFIN-EMBEDDED HUMAN BREAST CANCER TISSUE SPECIMENS. DELETIONS AND AMPLIFICATIONS OF THE TOP2A GENE SERVE AS A MARKER FOR POOR PROGNOSIS IN HIGH-RISK BREAST CANCER PATIENTS. RESULTS FROM THE TOP2A FISH PHARMDX KIT ARE INTENDED FOR USE A
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