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  5. Antimicrobial Susceptibility Test (AST) Systems - Class II Special Controls Guidance for Industry and FDA
  1. Guidance Documents (Medical Devices and Radiation-Emitting Products)

Antimicrobial Susceptibility Test (AST) Systems - Class II Special Controls Guidance for Industry and FDA

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This guidance document was developed as a special control guidance to support the reclassification of the antimicrobial susceptibility test (AST) system, when the device is a system employing short-term incubation (less than 16 hours) from class III into class II (special controls). The device is intended to determine the in vitro susceptibility of bacterial pathogens from clinical specimens.

 

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