Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DURASPHERE INJECTABLE BULKING AGENT

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

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC EIA

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

FDA Pre-Market Approval

FDA Class 3 ·ANTI-HBC

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 ·HBSAG REAGENT PACK/CALIBRATOR & CONFIRMATORY KIT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT R3 (PHEMFILCON A) LENSES/SHELF LIFE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) W/UV BLOCKER

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBSAG 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, LIAISON® XL MUREX Control anti-HBe

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·COOPERVISION (COMFILCON A) SOFT EXTENDED WEAR CONTACT LENSES

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

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Hepatitis B surface Antigen II (HBs11) and Atellica IM Hepatitis B surface Antigen 11 confirmatory (HBs11 Co

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT I1000 SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (ETAFILCON A) CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PERMALENS EXTENDED WEAR CONTACT LENS

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR & CONFIRMATORY KIT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT R3 (PHEMFILCON A) LENSES/SHELF LIFE

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

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLOSA ANTI-HBC EIA

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·POLYMACON SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES