232 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AMAX CS-190 COAGULATION ANALYZER SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
HEPARIN CONTROLS, HIGH AND LOW
FDA 510(k)
FDA Class 2
·Hematology
FACTOR XI DEFICIENT PLASMA
FDA 510(k)
FDA Class 2
·Hematology
SIGMA DIAGNOSTICS GLUCOSE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)
FDA 510(k)
FDA Class 2
·Hematology
ACCUSCAN MICROBEAD STANDARDS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INFINITY AST REAGENT (PROCEDURE NO. 51)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCUCOLOR HIGH CALIBRATOR (A3089)
FDA 510(k)
FDA Class 2
·Hematology
SIA THYROID STIMULATING HORMONE ELISA KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SIGMA ELECTROLYTE BUFFER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIGITOXIN FPIA CALIBRATOR SET
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SIGMA CX-3 CALIBRATION STANDARD LEVEL 1
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)
FDA 510(k)
FDA Class 2
·Hematology
VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334
FDA 510(k)
FDA Class 2
·Hematology
ACT CONTROL SET
FDA 510(k)
FDA Class 2
·Hematology
THROMBOPLATIN-M WITH CALCIUM
FDA 510(k)
FDA Class 2
·Hematology
ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245
FDA 510(k)
FDA Class 2
·Clinical Chemistry