Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·SOLESTA Injectable Gel

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control Anti-HBc

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CRYSTAL BLUE OPAQUE DURASOFT 3 HYDROPHILIC LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (ETAFILCONA) CONTACT LENSES, CLEAR & VISIBILITY TINRED WITH UV BLOCKER

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

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT AXSYM HBSAG & HBSAG CONFIRMATORY

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SAUFLON(R) PW (LIDOFILCON B)

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNDIAGNOSTICS PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (ETAFILCON A) CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (ETAFILCON A) CONTACT LENSES/CLEAR/VISIBILITY TINTED WITH UV BLOCKER

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS HBEAG

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/ IMMULITE 1000 AND IMMULITE 2000 HBSAG KITS.

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·OCUFILCON D SOFT ( HYDROPHILIC) CONTACT LENSES

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG/CONFIRMATORY

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBs II, PreciControl Anti-HBs

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SofLEns 38 (polymacon) Visibility Tinted Contact Lens