Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ANTI-HCV REAGENT PACK AND CALIBRATOR

VITROS Chemistry Products PHBR Slides

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS

FDA 510(k)

FDA Class 2 ·Microbiology

VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS XT Chemistry Products GLU-Ca Slides

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS CHEMISTRY PRODUCTS PHBR SLIDES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VITROS XT Chemistry Products TBIL-ALKP Slides

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702

FDA 510(k)

FDA Class 2 ·Hematology

VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS Chemistry Products Calibrator Kit 3

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS

FDA 510(k)

FDA Class 2 ·Immunology

VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry