FDA.reportPublic FDA data

SARS-CoV-2 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 severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent for COVID-19, in a clinical specimen.
GUDID devices
33
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00875197006759cobas SARS-CoV-2 Quality Control KitRoche Molecular Systems, Inc.094088351902026-02-24
00875197006858cobas® SARS-CoV-2 Qualitative Control KitRoche Molecular Systems, Inc.094461171902023-09-12
B540COV4100010Accula SARS CoV-2 Control KitMESA BIOTECH, INC.COV4100-12020-05-19
15420045517035Aptima®Hologic, Inc.SARS-COV-2 ASSAY CONTROLS, APTIMA, IVD2025-03-14
70845357044364QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.82682024-09-04
00816784020086ACCURUN®Lgc Clinical Diagnostics, Inc.0505-02272024-08-02
00816784020864ACCURUN®Lgc Clinical Diagnostics, Inc.0505-02202024-08-02
00860006589790ACCURUN®Lgc Clinical Diagnostics, Inc.0505-03002024-08-02
20816101027020Simplexa COVID-19 DirectDIASORIN MOLECULAR LLCMOL41502023-06-16
01220000260344NATtrol™ZEPTOMETRIX CORPORATIONNATtrol™ SARS-Related Coronavirus 2 Positive Contr2022-11-03
01220000260351NATtrol™ZEPTOMETRIX CORPORATIONNATtrol™ SARS-Related Coronavirus 2 Negative Contr2022-11-03
01220000260368NATtrol™ZEPTOMETRIX CORPORATIONNATtrol™ SARS-Related Coronavirus 2 Positive Contr2022-11-03
01220000260375NATtrol™ZEPTOMETRIX CORPORATIONNATtrol™ SARS-Related Coronavirus 2 Negative Contr2022-11-03
00811877011361ID NOW COVID-19 2.0 Control Swab KitAlere Scarborough, Inc.192-0802022-09-09
00812242030888Exact DiagnosticsEXACT DIAGNOSTICS, LLCCOV019CE2022-06-17
00812242030895Exact DiagnosticsEXACT DIAGNOSTICS, LLCCOV000CE2022-06-17
10845357043846Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0071N2022-02-16
10845357043853Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0072NS2022-02-16
10845357043945Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0073N2022-02-16
10845357043952Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0074NS2022-02-16
80845357043708QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.ABT-0012022-02-16
10845357043556Helix Elite™ Molecular Standards: Synthetic StandardMICROBIOLOGICS INC.HE0063S2020-12-17
10845357043563Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0065N2020-12-17
10845357043570Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0066NS2020-12-17
10845357043631Helix Elite™ Molecular Standards: Synthetic StandardMICROBIOLOGICS INC.HE0062-DN2020-12-17
00816784020987AccuPlex SARS-CoV-2 Molecular Controls Kit – Full GenomeLgc Clinical Diagnostics, Inc.0505-01592020-09-21
10845357043457Helix Elite™ Molecular Standards: Synthetic StandardMICROBIOLOGICS INC.HE0060S2020-08-10
10845357043464Helix Elite™ Molecular Standards: Synthetic StandardMICROBIOLOGICS INC.HE0061S2020-08-10
10845357043488Helix Elite™ Molecular Standards: Synthetic StandardMICROBIOLOGICS INC.HE0062S2020-08-10
00816784020918AccuPlex™ SARS-CoV-2 Molecular Controls kit Lgc Clinical Diagnostics, Inc.0505-01332020-07-09
00884999049208Alinity mABBOTT MOLECULAR INC.09N78-0852020-05-07
00884999049086RealTimeABBOTT MOLECULAR INC.09N77-0852020-04-27
10811877011276ID NOW™ COVID-19 Control Swab Kit Alere Scarborough, Inc.190-0802020-03-30