FDA.reportPublic FDA data

HIV1 nucleic acid IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of human immunodeficiency virus 1 (HIV1) nucleic acid in a clinical specimen.
GUDID devices
16
Last updated
2023-02-23 07:14:52

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850032683012Procleix HIV-1/HCV/HBV Quality ControlGRIFOLS DIAGNOSTIC SOLUTIONS INC.HIV-1 Positive Control2023-02-15
00884999047785Alinity mABBOTT MOLECULAR INC.08N45-0852020-09-09
00884883007512MAS HIV p24 Positive ControlMicrogenics Corporation100274812020-06-30
00884883005891Acrometrix BB NAT HIV-1 POS. CTRLMicrogenics Corporation9636022016-09-22
00884883006478Acrometrix HIV-1 Low ControlMicrogenics Corporation9640012018-06-15
00884883006485Acrometrix HIV-1 Mid ControlMicrogenics Corporation9640022018-06-15
00884883006546Acrometrix HIV-1 High ControlMicrogenics Corporation9640032018-06-15
00884883006928Acrometrix HIV p24Microgenics Corporation9600382018-04-13
00884999023932RealTimeABBOTT MOLECULAR INC.6L18-802016-07-01
00816784020550ACCURUN®Lgc Clinical Diagnostics, Inc.2020-00872016-09-24
00816784020567ACCURUN®Lgc Clinical Diagnostics, Inc.2020-00902016-09-24
00816784020574ACCURUN®Lgc Clinical Diagnostics, Inc.2020-00922016-09-24
00816784020802ACCURUN®Lgc Clinical Diagnostics, Inc.2020-00932016-09-24
00812242030017Exact DiagnosticsEXACT DIAGNOSTICS, LLCHIVL1012018-09-24
00812242030024Exact DiagnosticsEXACT DIAGNOSTICS, LLCHIVH1022018-09-24
00812242030581Exact DiagnosticsEXACT DIAGNOSTICS, LLCHIVLOD2018-09-24