THXID-BRAF KIT
FDA premarket approval P120014/S001 · decided 2015-01-30
Approval details
- PMA number
- P120014
- Supplement
- S001
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THXID-BRAF KIT
- Generic name
- Somatic gene mutation detection system
- Applicant
- bioMerieux, Inc.
- Date received
- 2014-10-10
- Decision date
- 2015-01-30
- Days to decision
- 112 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Hazelwood, MO
- Statement
- APPROVAL FOR A NEW DETERMINATION METHOD OF PLASMIDS AND TRANSCRIPTS CONCENTRATION DURING THE MANUFACTURING STEP (FGM/POL/ M00454), BY USING NANODROP UV-VIS SPECTROPHOTOMETER TO CHANGE FROM THE OLD METHOD UTILIZING STANDARD UV-VIS SPECTROPHOTOMETER.
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| VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) (K232963) | bioMerieux, Inc. | 2024-06-07 |
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