57 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
FDA Pre-Market Approval
FDA Class 3
·T-SPOT. TB TEST
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APILGRAF(GRAFTSKIN)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·AXSYM CORE 2.0
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·AXSYM CORE-M 2.0
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·BIO-RAD MONOLISA ANTI-HBC EIA
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ADAPTA, VERSA, SENSIA IPG. ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG, ENOUKSE E2 IOG, KAPPA D IPG,KAPPA DR IP
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IMG, Astra S DR MRI IG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra X
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ABBOTT ARCHITECT CORE ASSAY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·BIO-RAD MONOLISA ANTI-HBC EIA
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
FDA Pre-Market Approval
FDA Class 3
·BIOTRIN PARVOVIRUS IGM EIA (V619IMUS)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·AXSYM CORE 2.0 AND AXSYM CORE 2.0 CONTROLS
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
FDA classification
FDA Class 3
·Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·DIMENSION FPSA FLEX REAGENT CARTRIDGE
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR