154 results · 41ms · Sources: EU EUDAMED, US FDA

STANBIO LABORATORY

FDA registration
STANBIO LABORATORY·1 product·🇺🇸 United States

VISUWELL(R) REAGIN TEST (MODIFICATION)

FDA 510(k)
FDA Class 2 ·Microbiology

STANBIO LABORATORY

FDA registration
STANBIO LABORATORY·1 product·🇺🇸 United States

ELECSYS CA 15-3 II CALCHECK 5

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Beta-CrossLaps CalCheck 5

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

FLEXLAB 3.6, ACCELERATOR A3600

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MAGNETIC HDL CHOLESTEROL TEST

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HDL CHOLESTEROL PRECIPITATING REAGENT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HDL PRECIPITATING REAGENT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HDL CHOLESTEROL REAGENT SET

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

STAT TEST HDL/CHOLESTEROL TEST KIT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

COULTER HDL - CHOLESTEROL REAGENT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HDL EX-SEP PRECIPITATING REAGENT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HDL CHOLESTEROL PRETREATMENT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry