37 results
·
281ms
·
Sources: EU EUDAMED, US FDA
T2Bacteria® QCheck Positive Kit
FDA UDI
T2 BIOSYSTEMS, INC.·M70885080730·Positive ASK Control, Positive EPE Control
T2Candida 1.1 Panel
FDA 510(k)
FDA Class 2
·Microbiology
T2CANDIDA AND T2DX INSTRUMENT
FDA 510(k)
FDA Class 2
·Microbiology
T2Bacteria Panel
FDA 510(k)
FDA Class 2
·Microbiology
ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit
FDA 510(k)
FDA Class 2
·Microbiology
T2Candida 1.1 Panel
FDA 510(k)
FDA Class 2
·Microbiology
T2Bacteria® Panel
FDA 510(k)
FDA Class 2
·Microbiology
Alinity m
FDA UDI
ABBOTT MOLECULAR INC.·00884999050402·Alinity m HIV-1 Application Specification File
T2Biothreat® QCheck Negative Kit
FDA UDI
T2 BIOSYSTEMS, INC.·M70885113983·Negative quality control for T2Biothreat Panel
T2Biothreat® Reagent Trays
FDA UDI
T2 BIOSYSTEMS, INC.·M70880113943·The T2Biothreat Panel component that contains t...
T2Biothreat® Cartridge Kit
FDA UDI
T2 BIOSYSTEMS, INC.·M70890114000·The T2Biothreat Panel components used to load t...
BioFire® Global Fever Special Pathogens Panel
FDA UDI
BIOFIRE DEFENSE, LLC·00851458005273·BioFire® Global Fever Special Pathogens Panel -...
T2Biothreat® QCheck Positive Kit
FDA UDI
T2 BIOSYSTEMS, INC.·M70885113963·Buffer based solution with containing non-patho...
BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Pane
FDA UDI
BIOFIRE DEFENSE, LLC·00851458005280·BIOFIRE® SHIELD™ Control Kit for the BioFire Gl...
Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test
FDA classification
FDA Class 2
·Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test
Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.
FDA classification
FDA Class 2
·Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.
Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test
FDA classification
FDA Class 2
·Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test