Roche Receives the US FDA’s 510(k) Clearance for cobas Respiratory 4-flex for Comprehensive Respiratory Pathogen Detection
Shots:
- The US FDA has granted 510(k) clearance to cobas Respiratory 4-flex, which utilizes TAGS technology for simplification of respiratory testing & improving diagnostic speed as well as accuracy
- The cobas Respiratory 4-flex integrates seamlessly with cobas 5800, 6800 & 8800 systems to allow qualitative detection & differentiation of SARS-CoV-2, influenza A/B, as well as respiratory syncytial virus in nasopharyngeal swab samples from symptomatic pts
- TAGS (Temperature-Activated Generation of Signal) technology combines multiplex PCR with color, temperature, & data analysis to detect & distinguish multiple targets simultaneously within a single optical channel
Ref: Roche | Image: Roche| Press Release
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