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Multiple-type bloodstream 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 acids and/or genes conferring antimicrobial resistance from multiple types of microorganisms associated with bloodstream infection (i.e., bacteria, fungi, and viruses) in a clinical specimen and/or culture isolate.
GUDID devices
7
Last updated
2023-08-17 07:27:58

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00844509002437MDx-Chex for BC-GNSTRECK, INC.2500802023-08-09
00844509002468MDx-Chex for BC-GPSTRECK, INC.2500792023-08-09
70845357044098QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.82542022-02-16
00844509002338MDx-Chex for BCID2STRECK, INC.2500652022-01-25
00852720008077FilmArray BCID2 Control Panel M416Mmqciv.002021-02-18
10862011000335Accelerate PhenoTest BC ID QC testACCELERATE DIAGNOSTICS, INC.101051582018-02-01
10862011000342Accelerate PhenoTest BC AST QC testACCELERATE DIAGNOSTICS, INC.101061582018-02-01