1,260 results · 24ms · Sources: EU EUDAMED, US FDA

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT REAL TIME HCV GENOTYPE II, GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ARCHITECT ANTI-HCV REAGENT KITS, ARCHITECT ANTI-HCV CALIBRATORS, AND ARCHITECT ANTI-HCV CONTROLS

VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)

FDA 510(k)
FDA Class 2 ·Hematology

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval
FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·COBAS TaqMan HCV Test, v2.0, For use with the High Pure System, High Pure System Viral Nucleic Acid Kit

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·Alinity m CMV

Catheter Introducer Kit

FDA classification
FDA Class 2 ·Catheter Introducer Kit

Brachial Plexus Anesthesia Kit

FDA classification
FDA Class 2 ·Brachial Plexus Anesthesia Kit

Bone Marrow Collection/Transfusion Kit

FDA classification
FDA Class 2 ·Bone Marrow Collection/Transfusion Kit

Body Fluid Disposal Kit

FDA classification
FDA Class 2 ·Body Fluid Disposal Kit

General Surgery Tray

FDA classification
FDA Class 2 ·General Surgery Tray

Myringotomy Procedure Kit

FDA classification
FDA Class 2 ·Myringotomy Procedure Kit

Plaque Disclosing Kit

FDA classification
FDA Class 2 ·Plaque Disclosing Kit

Obstetrical Kit

FDA classification
FDA Class 2 ·Obstetrical Kit

Catheter Introducer Kit

FDA classification
FDA Class 2 ·Catheter Introducer Kit

Ct Biopsy Tray

FDA classification
FDA Class 2 ·Ct Biopsy Tray