Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·REFRESH CL(TM)/LUBRICATING AND REWETING DROPS

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB (R) EIA

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REAL TIME HCV GENOTYPE II, GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REAL TIME HCV ASSAY, ABBOTT REAL TIME HCV CALIBRATOR KIT AND CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA BALLOON CATHETERS, EXPRESS2 CORONARY STENT SYSTEM AND TAXUS EXPRESS2

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX TACROLIMUS II

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE (RF451)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·OraQuick HCV Rapid Antibody Test

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD/MONOCLONAL WHOLE BLOOD

Monitor, Apnea, Home Use

FDA classification

FDA Class 2 ·Monitor, Apnea, Home Use

Radioassay, Vitamin B12

FDA classification

FDA Class 2 ·Radioassay, Vitamin B12

Transferrin, Rhodamine, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Transferrin, Rhodamine, Antigen, Antiserum, Control

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHTECT ANTI-HCV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Alinity m CMV Assay

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD; AND CYCLOSPORINE MONOCLONAL WHOLE BLOOD

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·IMX AND AXSYM PSA

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX AFP ASSAY