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Multiple respiratory virus 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 one or multiple viruses associated with respiratory disease in a clinical specimen. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.
GUDID devices
32
Last updated
2023-11-02 06:48:15

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
15420045515376Panther Fusion®Hologic, Inc.KIT, SARS/FLU A/B/RSV CONTROLS, FUSION, IVD2023-10-25
00852720008091SPOTFIRE RSP Positive ControlMmqciv.002023-09-15
00852720008107SPOTFIRE RSP Negative ControlMmqciv.002023-09-15
00860006589714AccuPlex SARS-CoV-2, Flu A/B, and RSV Molecular Controls KitLgc Clinical Diagnostics, Inc.0505-02602023-07-17
20816101027150Simplexa COVID-19 & Flu A/B Positive Control Pack DIASORIN MOLECULAR LLCMOL42602023-06-16
01220000260320NATtrol™ZEPTOMETRIX CORPORATIONNATtrol™ Flu/RSV/SARS-CoV-2 Negative Control 2022-11-03
01220000260337NATtrol™ZEPTOMETRIX CORPORATIONNATtrol™ Flu/RSV/SARS-CoV-2 Positive Control2022-11-03
00812242030901Exact DiagnosticsEXACT DIAGNOSTICS, LLCCOVFLU2022-06-17
00812242030918Exact DiagnosticsEXACT DIAGNOSTICS, LLCCOVFLUNEG2022-06-17
00852720008114BioFire RP2.1/RP2.1plus Control Panel M441Mmqciv.002021-09-16
00884999049406Alinity mABBOTT MOLECULAR INC.09N79-0862021-03-10
70845357043602QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.82462020-12-17
10845357042023Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0028N2020-04-30
10845357042030Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0029N2020-04-30
10845357042047Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0030N2020-04-30
10845357042054Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0031N2020-04-30
10845357042061Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0032N2020-04-30
10845357042078Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0033N2020-04-30
10845357042177Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0043N2020-04-30
10845357042184Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0044N2020-04-30
10845357042214Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0050N2020-04-30
70845357041202QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.81902020-04-30
00852720008046FilmArray RP EZ Control Panel M265Mmqciv.002020-01-22
00852720008039FilmArray RP2/RP2plus Control PanelMmqciv.002019-12-31
00812242030840Exact DiagnosticsEXACT DIAGNOSTICS, LLCRPPOS2019-12-12
00812242030857Exact DiagnosticsEXACT DIAGNOSTICS, LLCRPNEG2019-12-12
70845357041240QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.8199 Cepheid Xpert® Respiratory Control Panel2019-10-31
00812242030758Exact DiagnosticsEXACT DIAGNOSTICS, LLCRPRC2019-09-19
20816101025552Simplexa™ Flu A/B & RSV Positive Control PackDIASORIN MOLECULAR LLCMOL26602016-09-22
30014613311072Quidel MolecularDIAGNOSTIC HYBRIDS, INC.M1072018-11-16
30014613311157Quidel MolecularDIAGNOSTIC HYBRIDS, INC.M1152018-11-16
30014613337003SolanaDIAGNOSTIC HYBRIDS, INC.M1232018-12-13