154 results
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41ms
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Sources: EU EUDAMED, US FDA
Filters
FDA FEI Number: 1616487
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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