Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
FDA product code SAN · 8 cleared devices
Class 2
Microbiology
- Regulation
- 21 CFR 866.1650
- Review panel
- MI
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2024-04-02 – 2026-07-08
Automated system that performs antimicrobial susceptibility testing using positive blood culture samples
SAN
2026-07-08
SAN
2026-06-26
PhAST instrument and PhAST Blood Culture Gram-negative Panel
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SAN
2026-04-15
ASTar BC G- Kit
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SAN
2025-10-27
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
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SAN
2024-10-23
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
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SAN
2024-06-20
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
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SAN
2024-04-26
ASTar BC G- Kit and ASTar Instrument
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SAN
2024-04-02
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System
View details →No matching devices.
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