Strip, Virulence, Corynebacterium Diphtheriae

Virulence Strip, Corynebacterium Diphtheriae is a laboratory device used in microbiology to test the toxigenicity of Corynebacterium diphtheriae isolates, determining whether a clinical isolate is capable of producing the diphtheria toxin and therefore poses a public health risk. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KFI, regulated under 21 CFR 866.3140, within the Microbiology medical specialty.