Title 21 Part 866 → Subpart B → §866.1640

Title 21 → Chapter I → Subchapter H → Part 866 → Subpart B → §866.1640

Electronic Code of Federal Regulations e-CFR

Title 21 Part 866 → Subpart B → §866.1640

e-CFR data is current as of January 23, 2020

Title 21Chapter ISubchapter HPart 866Subpart B → §866.1640

Title 21: Food and Drugs
Subpart B—Diagnostic Devices

§866.1640   Antimicrobial susceptibility test powder.

(a) Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

(b) Classification. Class II (performance standards).