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