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Multiple sexually transmitted pathogen 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 nucleic acid from multiple types of microorganisms associated with sexually transmitted infections (STI), in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include (but are not limited to) Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma species, Ureaplasma species, Treponema pallidum, Trichomonas vaginalis, herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2).
GUDID devices
22
Last updated
2020-09-22 07:47:39

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00847661002772AmpliTrolBIO-RAD LABORATORIES, INC.001262020-09-14
00847661002789AmpliClearBIO-RAD LABORATORIES, INC.001272020-09-14
00847661002796AmpliPROBEBIO-RAD LABORATORIES, INC.001382020-09-14
00884883007505MAS Omni Infectious BSI Positive Control PanelMicrogenics Corporation100274802020-06-30
10845357041989Helix Elite™ Molecular Standards: Synthetic StandardMICROBIOLOGICS INC.HE0047S2020-04-30
10845357042153Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0041N2020-04-30
10845357042160Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0042N2020-04-30
10845357042191Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0045N2020-04-30
70845357041196QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.81892020-04-30
70845357042681QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.82282020-04-30
70845357042728QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.82292020-04-30
00812242030741Exact DiagnosticsEXACT DIAGNOSTICS, LLCCTNGP2002019-09-19
70845357041080QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.8193 BD MAX™ CT/GC/TV 20-Day QC Panel2018-11-21
00884883006560Acrometrix CT/NG ControlMicrogenics Corporation9671462018-10-16
00884883006577Acrometrix Multi-Analyte Control HIV/HCV/HBV LowMicrogenics Corporation9671502018-08-21
00884883006584Acrometrix Multi-Analyte Control HIV/HCV/HBV HighMicrogenics Corporation9671512018-08-21
00884883006935Acrometrix TriScreenMicrogenics Corporation9608112018-04-05
00884999031128RealTimeABBOTT MOLECULAR INC.8L07-802016-09-01
00816784020673ACCURUN®Lgc Clinical Diagnostics, Inc.2025-00612018-09-24
00816784020680ACCURUN®Lgc Clinical Diagnostics, Inc.2025-00672018-09-24
00816784020697ACCURUN®Lgc Clinical Diagnostics, Inc.2025-00682018-09-24
00812242030512Exact DiagnosticsEXACT DIAGNOSTICS, LLCCTNGRC2018-09-24