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Multiple Candida species 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 species of the yeast Candida in a clinical specimen. Candida species intended to be detected may include Candida albicans, Candida dubliniensis, Candida glabrata, Candida kefyr, Candida krusei, Candida parapsilosis and/or Candida tropicalis.
GUDID devices
6
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
M70885049190T2Candida® External ControlsT2 BIOSYSTEMS, INC.85-049192017-02-12
M70885083750T2Candida® QCheck Positive KitT2 BIOSYSTEMS, INC.85-083752018-06-25
00850051429561Fort Worth DiagnosticsFort Worth Diagnostics, LLCCAURPOS2025-06-20
M70885083763T2Dx® QCheck Negative Kit T2 BIOSYSTEMS, INC.85-083762020-02-18
M70885083760T2Dx® QCheck Negative Kit T2 BIOSYSTEMS, INC.85-083762018-06-25
15420045512092Aptima®Hologic, Inc.CV/TV CONTROLS, APTIMA, 100T, IVD2019-07-02