230 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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ACCESS(R) TOTAL IGE ASSAY
FDA 510(k)
FDA Class 2
·Immunology
ACCESS VITAMIN B12 ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02
FDA 510(k)
FDA Class 2
·Hematology
ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS CORTISOL ASSAY (MODIFICATION)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS HTSH ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
KALLESTEAD TOTAL IGE MICROPLATE KIT
FDA 510(k)
FDA Class 2
·Immunology
ACCESS CK-MB REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS(R) CORTISOL REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS(R) FREE T4 ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS FREE T3 ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI
FDA 510(k)
FDA Class 2
·Immunology
QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
FDA 510(k)
FDA Class 2
·Medical Genetics
HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIOPLEX 2200 EBV IGG AND SYPHILIS IGG
FDA 510(k)
FDA Class 2
·Microbiology
ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND ALTERNARIA ALTERNATA WHICH ARE SPECIFIC IGEZR
FDA 510(k)
FDA Class 2
·Immunology
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VARIANT II HEMOGLOBIN A1C
FDA 510(k)
FDA Class 2
·Hematology
ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
ACCESS MYOGLOBIN REAGENTS
FDA 510(k)
FDA Class 2
·Immunology