342 results · 22ms · Sources: EU EUDAMED, US FDA

SIGMA DIAGNOSTICS CALICIUM REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SIGMA DIAGNOSTICS ACCUCLOT CONTROL I

FDA 510(k)
FDA Class 2 ·Hematology

ACCUCLOT CONTROL I, MODEL A4089

FDA 510(k)
FDA Class 2 ·Hematology

FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

HEPARIN ADSORBENT

FDA 510(k)
FDA Class 2 ·Hematology

CS-400 COAGULATION ANALYZER SYSTEM (A1208)

FDA 510(k)
FDA Class 2 ·Hematology

DIGOXIN DG-II FPIA REAGENT SET

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

SIGMA CX-3 CALIBRATION STANDARD LEVEL 2

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY

FDA 510(k)
FDA Class 2 ·Hematology

SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SIGMA DIAGNOSTICS BUN REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096

FDA 510(k)
FDA Class 2 ·Hematology

MONOCLONAL ANTIBODY ANTI-CD19

FDA 510(k)
FDA Class 2 ·Hematology

SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A

FDA 510(k)
FDA Class 2 ·Hematology

AMYLASE REAGENT (PROCEDURE 577)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

PRIMIDONE FPIA REAGENT SET AND CALIBRATORS

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

SIGMA BUN REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry