Selux Diagnostics’ PBC Separator with Selux AST System Gains the US FDA’s 510(k) Clearance for Antibiotic Susceptibility Testing
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- The US FDA has granted 510(k) clearance to the company’s Positive Blood Culture (PBC) Separator with Selux AST System for antibiotic susceptibility testing
- The Selux PBC Separator enables labs to directly test positive blood culture by automatically preparing the sample for susceptibility testing, eliminating the need for subculturing. It assesses a bacteria's susceptibility to 17 specific antibiotic agents on the Selux Gram Negative Panel
- The Selux PBC Separator has previously received the US FDA’s Breakthrough Device Designation for its ability to meet the need for performing AST directly from positive blood culture & other sterile body fluids
Ref: Newswire | Image: Selux Diagnostics
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
