Vysis ALK Break Apart Fish Probe Kit
FDA premarket approval P110012/S020 · decided 2020-05-22
Approval details
- PMA number
- P110012
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Vysis ALK Break Apart Fish Probe Kit
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2019-12-23
- Decision date
- 2020-05-22
- Days to decision
- 151 days
- Decision code
- APPR
- Product code
- OWE
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- Approval of the expansion of the Indications for Use for the Vysis ALK Break Apart FISH Probe Kit to include an indication for ALUNBRIG® (brigatinib). The device, as modified, will be marketed under the trade name Vysis ALK Break Apart FISH Probe Kit and is indicated for:INTENDED USE The Vysis ALK Break Apart FISH Probe Kit is a qualitative test to detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) tissue specimen
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