608 results
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40ms
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Sources: EU EUDAMED, US FDA
i-STAT TBI Cartridge with the i-STAT Alinity System
FDA 510(k)
FDA Class 2
·Immunology
i-STAT TBI Plasma cartridge with the i-STAT Alinity System
FDA 510(k)
FDA Class 2
·Immunology
VIDAS TBI (GFAP, UCH-L1)
FDA 510(k)
FDA Class 2
·Immunology
Traumatic brain injury (TBI) test
FDA 510(k)
FDA Class 2
·Immunology
Brain Trauma Assessment Test
FDA classification
FDA Class 2
·Brain Trauma Assessment Test
Lumipulse G TP-N Calibrators
FDA registration
Fujirebio Inc.·1 product·🇯🇵 Japan
Syphilis IgM
FDA registration
Diagnostic Automation/ Cortez Diagnostics Inc,.·1 product·🇺🇸 United States
Trinity Biotech Uni-Gold Syphilis Treponemal Test Kit
FDA registration
Trinity Biotech USA·1 product·🇺🇸 United States
Antigen Substrate Slide
FDA registration
BION ENTERPRISES, LTD.·1 product·🇺🇸 United States
Anti-Borrelia burgdorferi US WESTERNBLOT (IgG)
FDA registration
EUROIMMUN Medizinische Labordiagnostika AG·1 product·🇩🇪 Germany
Borrelia All-In-One ViraChip Test Kit
FDA registration
VIRAMED BIOTECH AG·1 product·🇩🇪 Germany
Virgo FTA ABS IFA Kit
FDA registration
HEMAGEN DIAGNOSTICS, INC.·1 product·🇺🇸 United States
Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit
FDA registration
GOLD STANDARD DIAGNOSTICS, LLC·1 product·🇺🇸 United States
LSR / REAGENT, BORRELIA SEROLOGICAL REAGENT
FDA registration
MONOCENT INC.·1 product·🇺🇸 United States
LABORATORIOS SCANTIBODIES S.A. DE C.V.
FDA registration
LABORATORIOS SCANTIBODIES S.A. DE C.V.·1 product·🇲🇽 Mexico
B. burgdorferi IgG/IgM ELIA, EIA-2809
FDA registration
DRG INSTRUMENTS GMBH·1 product·🇩🇪 Germany
Borrelia B31 ViraChip IgG Test Kit
FDA registration
VIRAMED BIOTECH AG·1 product·🇩🇪 Germany
Lyme B. burgdorferi (IgM) MarStripe Test
FDA registration
IMMCO DIAGNOSTICS, INC.·1 product·🇺🇸 United States
NITTOBO MEDICAL CO., LTD. MEDICAL DEVELOPMENT CENTER
FDA registration
NITTOBO MEDICAL CO., LTD. MEDICAL DEVELOPMENT CENTER·1 product·🇯🇵 Japan
Syphilis IgM
FDA registration
IMMUNOCENTRIX CORPORATION·1 product·🇺🇸 United States