Device |
point of care hiv serology diagnostic and/or supplemental test |
Definition |
Human immunodeficiency virus (HIV) Point of Care serological diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV antigen(s) and/or detection of antibodies against HIV in human body fluids or tissues. |
Product Code | QSU |
Regulation Number |
866.3956
|
Device Class |
2
|
|
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