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Multiple gastrointestinal pathogen nucleic acid IVD, kit, microarray

Definition
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types microorganisms associated with gastrointestinal disease, in a clinical specimen, using a microarray method. Microorganisms detected may include bacteria, viruses, fungi and/or parasites such as, but are not limited to Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Norovirus, Rotavirus, Clostridium difficile, Giardia, Bacillus and/or Vibrio species.
GUDID devices
9
Last updated
2019-04-03 22:55:27

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B178GBSTEC102Shiga Toxin Direct TestGREAT BASIN SCIENTIFIC, INC.GBSTEC-102016-09-23
00857573006041Enteric Pathogens (EP) Nucleic Acid Test CartridgeNANOSPHERE, INC.20-006-0232016-09-23
00857573006058Enteric Pathogens (EP) Extraction TrayNANOSPHERE, INC.20-009-0232016-09-23
00857573006065Enteric Pathogens (EP) Stool Sample Preparation KitNANOSPHERE, INC.30-002-0232016-09-23
00857573006089Enteric Pathogens (EP) Amplification TrayNANOSPHERE, INC.20-011-0232016-09-23
00857573006157Clostridium difficile (CDF) Nucleic Acid Test CartridgeNANOSPHERE, INC.20-006-0222016-09-23
00857573006256Clostridium difficile (CDF) Extraction TrayNANOSPHERE, INC.20-009-0222016-09-23
00857573006317Clostridium difficile (CDF) Amplification TrayNANOSPHERE, INC.20-011-0222016-09-23
00857573006362Clostridium difficile (CDF) Stool Sample Preparation KitNANOSPHERE, INC.30-002-0222016-09-23