BIOMERIEUX THXID BRAF ASSAY KIT
FDA premarket approval P120014 · decided 2013-05-29
Approval details
- PMA number
- P120014
- Trade name
- BIOMERIEUX THXID BRAF ASSAY KIT
- Generic name
- Somatic gene mutation detection system
- Applicant
- bioMerieux, Inc.
- Date received
- 2012-07-31
- Decision date
- 2013-05-29
- Days to decision
- 302 days
- Decision code
- APWD
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- Yes
- Location
- Hazelwood, MO
- Statement
- APPROVAL FOR THE THXID BRAF KIT FOR USE ON THE ABI 7500 FAST DX REAL-TIME PCR INSTRUMENT. THIS DEVICE IS INDICATED FOR: THE THXID BRAF KIT IS AN IN VITRO DIAGNOSTIC DEVICE INTENDED FOR THE QUALITATIVE DETECTION OF THE BRAF V600E AND V600K MUTATIONS IN DNA SAMPLES EXTRACTED FROM FORMALIN-FIXED PARAFFINEMBEDDED (FFPE) HUMAN MELANOMA TISSUE. THE THXID BRAF KIT IS A REAL-TIME PCR TEST ON THE ABI 7500 FAST DX SYSTEM AND IS INTENDED TO BE USED AS AN AID IN SELECTING MELANOMA PATIENTS WHOSE TUMORS CARR
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