409 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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GLYC-AFFIN(TM)-GA
FDA 510(k)
FDA Class 2
·Hematology
OneDraw A1C Test System
FDA 510(k)
FDA Class 2
·Hematology
POLYMEDCO HBA1C TEST
FDA 510(k)
FDA Class 2
·Hematology
skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)
FDA 510(k)
FDA Class 2
·Hematology
NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY
FDA 510(k)
FDA Class 2
·Hematology
ABBOTT VISION(TM) GLYCATED HB
FDA 510(k)
FDA Class 2
·Hematology
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,
FDA 510(k)
FDA Class 2
·Hematology
TECHNIQUE, CHROMATOGRAPHIC, HEMOGLOBIN
FDA 510(k)
FDA Class 2
·Hematology
ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S
FDA 510(k)
FDA Class 2
·Hematology
TINA-QUANT HEMOGLOBIN A1C
FDA 510(k)
FDA Class 2
·Hematology
DIMENSION VISA HBA1C, MODEL K3105A
FDA 510(k)
FDA Class 2
·Hematology
LYOPHILIZED G-HB QUIK COLUMN CONTROL
FDA 510(k)
FDA Class 2
·Hematology
HBA1C ENZYMATIC ASSAY
FDA 510(k)
FDA Class 2
·Hematology
ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
FDA 510(k)
FDA Class 2
·Hematology
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT
FDA 510(k)
FDA Class 2
·Hematology
Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set
FDA 510(k)
FDA Class 2
·Hematology
GLYCA-DIRECT FRUCTOSAMINE
FDA 510(k)
FDA Class 2
·Hematology
GLUCOHEMOGLOBIN CONTROL
FDA 510(k)
FDA Class 2
·Hematology
GLYCOSYLATED HEMOGLOBIN-SMC COLUMN
FDA 510(k)
FDA Class 2
·Hematology