Medical devices: immunology and microbiology devices: classification of in vitro human immunodeficiency virus drug resistance genotype assay. Final rule.

Abstract excerpt

The Food and Drug Administration (FDA) is classifying an in vitro human immunodeficiency virus (HIV) drug resistance genotype assay into class II (special controls). The special control that will apply to this device is the guidance document entitled "Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay." FDA is classifying the device into class II (special controls) in order...

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