Clostridium difficile 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, including specific gene markers, from Clostridium difficile bacteria [e.g., genes conferring antimicrobial resistance (e.g., gyrA gene), virulence (e.g., ribotype 027), and genes encoding toxin A and/or B] in a clinical specimen and/or culture isolate.
GUDID devices
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Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
70845357041370QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.8200 Cepheid Xpert® C. difficile/Epi Control Panel2019-05-31
01220000260054NATtrol™ZEPTOMETRIX CORPORATIONNATtrol™ Clostridium difficile Positive Control 2020-10-15
01220000260061NATtrol™ZEPTOMETRIX CORPORATIONNATtrol™ Clostridium difficile Negative Control 2020-10-15
70845357042711QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.82272020-04-30
00840733101120illumigene C. difficile External Control KitMERIDIAN BIOSCIENCE, INC.2799202016-09-23
00840733102134Alethia™ C. difficile External Control KitMERIDIAN BIOSCIENCE, INC.4799202019-01-09
00812242030734Exact DiagnosticsEXACT DIAGNOSTICS, LLCCDFP2002019-09-19
30014613311089Quidel MolecularDIAGNOSTIC HYBRIDS, INC.M1082018-11-16
00847661005926AmplichekBIO-RAD LABORATORIES, INC.120002012016-09-19
00847661005971AmplichekBIO-RAD LABORATORIES, INC.120005762016-09-19