43 results · 20ms · Sources: EU EUDAMED, US FDA

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Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·therascreen PIK3CA RGQ PCR Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·therascreen PIK3CA RGQ PCR Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·therascreen® PIK3CA RGQ PCR Kit

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·RX HERCULINK ELITE RENAL STENT SYSTEM

Qualitative And Quantitative Hepatitis B Virus Antibody Assays

FDA Pre-Market Approval
FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·Vitros Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·VITROS ANTI-HBE

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·RX HERCULINK ELITE RENAL STENT SYSTEM

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·VITROS Anti-HBe

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·RX HERCULINK ELITE RENAL STENT SYSTEM

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·RX Herculink Elite

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·RX Herculink Elite Renal Stent System

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·RX Herculink Elite Renal and Biliary Stent System

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·ADAPTER 2D MATRIX BARCODE VERIFICATION SYSTEM

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·RX HERCULINK ELITE RENAL STENT SYSTEM

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·RX HERCULINK ELITE RENAL AND BILIARY STENT SYSTEM

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator