Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
Microbiology · 21 CFR 866.1650
Automated system that performs antimicrobial susceptibility testing using positive blood culture samples
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
9 firms currently registered for this product code
510(k) clearances
8 clearances for this product code
- bioMerieux, Inc.Jul 8, 2026
K260160 · VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
- Phast Corp.Jun 26, 2026
K253316 · PhAST instrument and PhAST Blood Culture Gram-negative Panel
- Q-Linea ABApr 15, 2026
K253573 · ASTar BC G- Kit
- Affinity Biosensors, LLCOct 27, 2025
K251875 · LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
- Affinity Biosensors, LLCOct 23, 2024
K241324 · LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
- Specific Diagnostics, LLCJun 20, 2024
K230675 · VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
- Q-Linea ABApr 26, 2024
K221688 · ASTar BC G- Kit and ASTar Instrument
- Affinity BiosensorsApr 2, 2024
K211815 · LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System