CLSI M100

Performance Standards for Antimicrobial Susceptibility Testing

Body

CLSI

Number

CLSI M100

FDA recognition no.

7-328

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Exceptions are noted on the FDA Antimicrobial Susceptibility Test Interpretive Criteria (STIC) webpage (https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm575163.htm). In the absence of interpretive criteria and quality control parameters on this FDA webpage, consult the technical contacts below.

Scope source: FDA 认可共识标准库

Laboratories covering this standard