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