Gram-negative bacteria and associated resistance markers

Product	Model	Company	Device type
Accelerate PhenoTest BC AST QC testAccelerate Diagnostics, Inc.Multiple-type bloodstream pathogen nucleic acid IVD, control	10106158	Accelerate Diagnostics, Inc.	Multiple-type bloodstream pathogen nucleic acid IVD, control
Accelerate Pheno™ SystemAccelerate Diagnostics, Inc.Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry	10301008	Accelerate Diagnostics, Inc.	Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
ACCUPROBE®Hologic, Inc.Mycobacterium tuberculosis nucleic acid IVD, kit, nucleic acid technique (NAT)	KIT,ACCUPROBE,M. TUBERCULOSIS	Hologic, Inc.	Mycobacterium tuberculosis nucleic acid IVD, kit, nucleic acid technique (NAT)
BD MAX™ Extended Enteric Bacterial PanelBecton, Dickinson and CompanyMultiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)	443812	Becton, Dickinson and Company	Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
BioFire® Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLCMultiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry	RFIT-ASY-0148	Biofire Diagnostics, LLC	Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
ePlexGenmark Diagnostics, Inc.Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry	BCID_FP Cartridge Pouch	Genmark Diagnostics, Inc.	Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
ePlexGenmark Diagnostics, Inc.Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry	BCID-FP 12 Kit Box	Genmark Diagnostics, Inc.	Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
eTube Disposable - Box of 20Avails Medical, Inc.Assay container IVD, single-use	6001	Avails Medical, Inc.	Assay container IVD, single-use
Gram-Negative Blood Culture (BC-GN) Extraction TrayLuminex CorporationMultiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)	20-009-021	Luminex Corporation	Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Gram-Negative Blood Culture (BC-GN) Utility TrayLuminex CorporationMultiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)	20-011-021	Luminex Corporation	Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Gram-Positive Blood Culture (BC-GP) Extraction TrayLuminex CorporationMultiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)	20-009-018	Luminex Corporation	Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test CartridgeLuminex CorporationMultiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)	20-006-018	Luminex Corporation	Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
iC-GN AssayIcubate, IncMultiple bloodstream bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)	iCC-AAQA00000	Icubate, Inc	Multiple bloodstream bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
LIAISON PLEX Yeast Blood Culture Assay KitLuminex CorporationMultiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)	20-005-306	Luminex Corporation	Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
MDx-Chex for BCID2Streck, Inc.Multiple-type bloodstream pathogen nucleic acid IVD, control	250065	Streck, Inc.	Multiple-type bloodstream pathogen nucleic acid IVD, control
NG-Test CARBA 5Ng BiotechBacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit	Kit of 20 tests for US	Ng Biotech	Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit
RAPIDEC® CARBA NPBiomerieux SAMultiple bacteria carbapenemase production IVD, kit, chromogenic	RAPIDEC® CARBA NP	Biomerieux SA	Multiple bacteria carbapenemase production IVD, kit, chromogenic
Simplexa™ C. auris DirectDiasorin Molecular LLCCandida auris nucleic acid IVD, kit, nucleic acid technique (NAT)	MOL3950	Diasorin Molecular LLC	Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT)
Simplexa™ C. auris Positive Control PackDiasorin Molecular LLCCandida auris nucleic acid IVD, kit, nucleic acid technique (NAT)	MOL3960	Diasorin Molecular LLC	Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT)
Simplexa™ C. auris Sample Prep KitDiasorin Molecular LLCCandida auris nucleic acid IVD, kit, nucleic acid technique (NAT)	MOL5390	Diasorin Molecular LLC	Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT)
T2Bacteria® QCheck Negative KitT2 Biosystems, Inc.Multiple bloodstream bacteria nucleic acid IVD, control	85-08074	T2 Biosystems, Inc.	Multiple bloodstream bacteria nucleic acid IVD, control
T2Bacteria® QCheck Positive KitT2 Biosystems, Inc.Multiple bloodstream bacteria nucleic acid IVD, control	85-07191	T2 Biosystems, Inc.	Multiple bloodstream bacteria nucleic acid IVD, control
T2Bacteria® Reagent TraysT2 Biosystems, Inc.Multiple-type bloodstream pathogen nucleic acid IVD, reagent	80-07342	T2 Biosystems, Inc.	Multiple-type bloodstream pathogen nucleic acid IVD, reagent
T2Candida® External ControlsT2 Biosystems, Inc.Multiple Candida species nucleic acid IVD, control	85-04919	T2 Biosystems, Inc.	Multiple Candida species nucleic acid IVD, control
T2Candida® QCheck Positive KitT2 Biosystems, Inc.Multiple Candida species nucleic acid IVD, control	85-08375	T2 Biosystems, Inc.	Multiple Candida species nucleic acid IVD, control