4,971 results · 43ms · Sources: EU EUDAMED, US FDA

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Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT CORE-M

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT HBSAG QUALITATIVE(LN 4P53), ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54) ASSAYS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·Vitros Immunodiagnostic Products HBs Ag Reagent Pack and Calibrator

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·Elecsys Anti-HBe, PreciControl Anti-HBe

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT CORE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·QUASEPT II

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophillic) Contact Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·VISTAKON (senofilcon A) ACUVUE OASYS Brand Contact Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·LOTRAFILCON B SOFT CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·PERMAFLEX NATURALS (SURFILCON A) AND PERMAFLEX UV NATURALS (VASURFILCON A) HYDROPHILIC CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY (comfilcon A) Soft (Hydrophilic) Contact Lenses

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·LIAISON XL MUREX HBsAg Qual, LIAISON XL MUREX Control HBsAg Qual

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS ANTI-HBS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Comflicon A Soft (Hydrophilic ) Extended Wear Contact Lenses

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS HBEAG IMMUNOASSAY AND ELECSYS PRECICONTROL HBEAG

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT AUSAB

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·Atellica IM Hepatitis B core IgM (aHBcM) Assay

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODICTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR