important tools / oral fluid collection device / final product / specimen processing / manufacturing consistency / specimen processing reagents / chemical nature / manufacturing / blood bank practices / subsequent processing steps / /
MedicalCondition
HIV / Sterility / HIV RNA / infectious agent / /
Organization
U. S. Department of Health and Human Services / Center for Devices and Radiological Health / HIV ELISAs / U.S. Food and Drug Administration / Radiological Health / Center for Biologics Evaluation and Research / office of Communication / Training and Manufacturers Assistance / Center for Devices / / /
Position
control/calibrator / physician / General / /
ProgrammingLanguage
Latex / /
ProvinceOrState
Maryland / /
Technology
ion exchange / specific 7 technology / electrophoresis / diagnostic tests / antibodies / hybridization / DNA sequencing / In vitro diagnostics / /
Guidance In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of HIV Types 1 and 2