Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker

FDA 510(k)

FDA Class 2 ·Immunology

SPIFE A1AT kit

FDA 510(k)

FDA Class 2 ·Immunology

ICATH, STERILESURE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Abbott Real Time HCV Genotype II Amplification Reagent Kit / HCV Genotype II Control Kit

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·ARTUS CMV RGQ MDX KIT

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·ARTUS CMV RGQ MDX KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA TEST KIT

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ETI-HA-IGMK PLUS KIT

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC BIG RANGER PTCA CATHETER

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB-M EIA DIAGNOSTIC KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-EIA DIAGNOSTIC TEST KIT

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ETI-HA-IGMK PLUS KIT

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·ARTUS CMV RGQ MDX KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA--RIA DIXGNOSTIC TEST KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-RIA DIAGNOSTIC TEST KIT

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT Anti-HCV Reagent Kit

Enzyme Immunoassay, Cannabinoids

FDA Pre-Market Approval

FDA Class 2 ·DR. BROWN'S HOME DRUG TESTING KIT

Enzyme Immunoassay, Cannabinoids

FDA Pre-Market Approval

FDA Class 2 ·DR. BROWN'S HOME DRUG TESTING KIT

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·PRO-TRAC II TACROLIMUS ELISA KIT

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Alinity i Anti-HCV Reagent Kit