Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ANTI-HCV REAGENT PACK AND CALIBRATOR

VITROS Immunodiagnostic Products CEA Reagent Pack

FDA 510(k)

FDA Class 2 ·Immunology

VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack

FDA 510(k)

FDA Class 2 ·Immunology

VITROS BRAHMS PCT Reagent Pack and Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

VITROS Chemistry Products hsCRP Reagent

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS Immunodiagnostic Products CK-MB Reagent Pack

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

THE VITROS 5,1 FS CHEMISTRY SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

VITROS Chemistry Products Cl- Slides

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7

FDA 510(k)

FDA Class 2 ·Immunology

VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS AFP

FDA 510(k)

FDA Class 2 ·Immunology

VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303

FDA 510(k)

FDA Class 2 ·Clinical Chemistry