59 results
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77ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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BIO-RAD D-10 DUAL PROGRAM
FDA 510(k)
FDA Class 2
·Hematology
VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730
FDA 510(k)
FDA Class 2
·Hematology
ACCESS CORTISOL REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM
FDA 510(k)
FDA Class 2
·Hematology
D-10 HEMOGLOBIN A1C
FDA 510(k)
FDA Class 2
·Hematology
ACCESS TOTAL BHCG ASSAY (MODIFICATION)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MONOLISA ANTI-HAV EIA
FDA 510(k)
FDA Class 2
·Microbiology
ACCESS DIGOXIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
D-100 HbA1c, D-100 HbA1c Calibrator Pack
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS THYROID UPTAKE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET
FDA 510(k)
FDA Class 2
·Microbiology
VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU
FDA 510(k)
FDA Class 2
·Hematology
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