2,477 results
·
48ms
·
Sources: EU EUDAMED, US FDA
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·Aptima HPV-GT Assay
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·LIAISON® XL Murex Anti-HBe and LIAISON® XL Murex Control Anti-HBe
Assay, Genotyping, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·Abbott RealTime HCV GT II
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·RealTime HBV
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·LIAISON® XL Murex Anti-HBs, LIAISON® XL Murex Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·LIAISON® XL Murex HBeAg and LIAISON® XL Murex Control HBeAg
Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
FDA Pre-Market Approval
FDA Class 3
·T SPOT-TB TEST
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·Abbott RealTime CMV
Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
FDA Pre-Market Approval
FDA Class 3
·EGFR pharmDx
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·RealTime HCV
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·Praxis Extended RAS Panel
THE BULLION
FDA 510(k)
FDA Class 2
·Radiology
OCTOPAQUE UNIVERSAL
FDA 510(k)
FDA Class 2
·Radiology
CALM CURVE, VERSION 01.00
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LITTLE PRISM
FDA 510(k)
FDA Class 2
·Radiology
BRACHYSEED
FDA 510(k)
FDA Class 2
·Radiology
BRACHYSEED PD-103 MODELS #PD1
FDA 510(k)
FDA Class 2
·Radiology
CALM PATTERNS, VERSION 01.00.00
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GENTLE SLOPE
FDA 510(k)
FDA Class 2
·Radiology
OCTOSTOP COMPENSATING FILTERS
FDA 510(k)
FDA Class 2
·Radiology