DAKOCYTOMATION HER2 FISH PHARMDX KIT
FDA premarket approval P040005 · decided 2005-05-03
Approval details
- PMA number
- P040005
- Trade name
- DAKOCYTOMATION HER2 FISH PHARMDX KIT
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- Date received
- 2004-01-29
- Decision date
- 2005-05-03
- Days to decision
- 460 days
- Decision code
- APPR
- Product code
- MVD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Singapore
- Statement
- APPROVAL FOR THE DAKOCYTOMATION HER2 FISH PHARMDX KIT. THE DEVICE IS INDICATED FOR: THE DAKOCYTOMATION HER2 FISH PHARMDX KIT IS A DIRECT FLUORESCENCE IN SITU HYBRIDIZATION (FISH) ASSAY DESIGNED TO QUANTITATIVELY DETERMINE THE HER2 GENE AMPLIFICATION IN FORMALIN-FIXED, PARAFFIN-EMBEDDED BREAST CANCER TISSUE SPECIMENS. HER2 FISH PHARMDX KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED. RESULTS FORM THE HER2 FISH PHARMDX KIT ARE
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