Product code NHS

Device name

Assay, Genotype, Hiv Drug Resistance, In Vitro

Medical specialty

Immunology

Device class

2

Regulation number

866.3950

Review panel

IM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

Hiv-1 drug resistance genotyping

Source

FDA openFDA device classification dataset