Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·AIR, OPTIX, AQUA, MULTIFOCAL (lotrafilcon B) Soft Contact Lenses for daily and extended wear

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFLENS (POLYMACON) CONTACT LENSES

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBSAG ASSAY

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOMEDICS 55(OCUFILCON D) UV BLOCKING SOFT(HYDROPHILIC) CONTACT LENS(EXTENDED WEAR)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOF-FORM 55 EW AND LL-55 SOFT HYDROPHILIC SPHERICAL CONTACT LENSES

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS ASSAY

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

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

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

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 AND CALIBRATOR/CONFIRMATORY KIT

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY,

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

FDA Pre-Market Approval

FDA Class 3 ·Alinity i Anti-HBs Reagent Kit (2x 100 Tests), Alinity i Anti-HBs Reagent Kit (2x600 Tests), Alinity i Anti-HBs Reagent

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·COAPTITE INJECTABLE IMPLANT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON XL MUREX HBsAg Qual and LIAISON XL MUREX Control HBsAg Qual and LIAISON XL MUREX HBsAg Confirmatory

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 ·SOFLENS(R) (POLYMACON) P.A.1 SERIES

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 ·IMMULITE/IMMULITE 1000 & IMMULITE 2000 HBSAG & IMMULITE/IMMULITE 1000/IMMULITE 2000 HBSAG CONFIRMATORY

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFLENS