10,000 results · 70ms · Sources: EU EUDAMED, US FDA

AUTOMATED WORKCELL CONTROL SOFTWARE

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Alpha-1 Microglobulin, Antigen, Antiserum, Control

FDA classification
FDA Class 1 ·Alpha-1 Microglobulin, Antigen, Antiserum, Control

Ceruloplasmin, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Ceruloplasmin, Antigen, Antiserum, Control

Radioimmunoassay, Methaqualone

FDA classification
FDA Class 2 ·Radioimmunoassay, Methaqualone

Alcohol Control Materials

FDA classification
FDA Class 1 ·Alcohol Control Materials

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Pre-Market Approval
FDA Class 1 ·ABBOTT ARCHITECT TOTAL PSA

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Pre-Market Approval
FDA Class 1 ·ABBOTT AXSYM TOTAL PSA ASSAY

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Pre-Market Approval
FDA Class 1 ·ABBOTT IMX TOTAL PSA

Alpha-2-Macroglobulin, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Alpha-2-Macroglobulin, Antigen, Antiserum, Control

Fluorescent Immunoassay, Tobramycin

FDA classification
FDA Class 2 ·Fluorescent Immunoassay, Tobramycin

Igm, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Igm, Antigen, Antiserum, Control

Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet

FDA classification
FDA Class 2 ·Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet

Electrode, Ion Specific, Urea Nitrogen

FDA classification
FDA Class 2 ·Electrode, Ion Specific, Urea Nitrogen

Antithrombin Iii Quantitation

FDA classification
FDA Class 2 ·Antithrombin Iii Quantitation

Calibrators, Ethyl Alcohol

FDA classification
FDA Class 2 ·Calibrators, Ethyl Alcohol

Ph Rate Measurement, Carbon-Dioxide

FDA classification
FDA Class 2 ·Ph Rate Measurement, Carbon-Dioxide

Photometric Method, Magnesium

FDA classification
FDA Class 1 ·Photometric Method, Magnesium

Calibrator For Hemoglobin And Hematocrit Measurement

FDA classification
FDA Class 2 ·Calibrator For Hemoglobin And Hematocrit Measurement

Lambda, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Lambda, Antigen, Antiserum, Control

Kappa, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Kappa, Antigen, Antiserum, Control