Multiple-type 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 of 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
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840487101520Enteric Pathogens (EP) Nucleic Acid Test CartridgeLUMINEX CORPORATION20-006-0232019-12-05
00840487101544Enteric Pathogens (EP) Amplification TrayLUMINEX CORPORATION20-011-0232019-12-05
00840487101551Enteric Pathogens (EP) Extraction TrayLUMINEX CORPORATION20-009-0232019-12-05
00840487101568Enteric Pathogens (EP) Stool Sample Preparation KitLUMINEX CORPORATION30-002-0232019-12-05
00840487101605Clostridium difficile (CDF) Nucleic Acid Test CartridgeLUMINEX CORPORATION20-006-0222019-12-05
00840487101650Clostridium difficile (CDF) Extraction TrayLUMINEX CORPORATION20-009-0222019-12-05
00840487101704Clostridium difficile (CDF) Amplification TrayLUMINEX CORPORATION20-011-0222019-12-05
00840487101735Clostridium difficile (CDF) Stool Sample Preparation KitLUMINEX CORPORATION30-002-0222019-12-05
B178GBSTEC100Shiga Toxin Direct TestGREAT BASIN SCIENTIFIC, INC.GBSTEC-102016-09-23