88 results
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168ms
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Sources: EU EUDAMED, US FDA
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Fda510k
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ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MONOLISA ANTI-HAV IGM EIA
FDA 510(k)
FDA Class 2
·Microbiology
VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE
FDA 510(k)
FDA Class 2
·Hematology
VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH
FDA 510(k)
FDA Class 2
·Hematology
MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM
FDA 510(k)
FDA Class 2
·Hematology
VARIANT(TM) II TURBO HBA1C KIT - 2.0
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
VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
FDA 510(k)
FDA Class 2
·Hematology