1,642 results
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170ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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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
ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05
FDA 510(k)
FDA Class 1
·Clinical Chemistry
KALLESTAD RSV MICROPLATE EIA
FDA 510(k)
FDA Class 1
·Microbiology
ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
ACCESS CHLAMYDIA ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
ACCESS MYOGLOBIN REAGENTS
FDA 510(k)
FDA Class 2
·Immunology
LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCESS ALLERGEN DOG EPITHELIM
FDA 510(k)
FDA Class 2
·Immunology
ACCESS TOTAL BHCG ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK
FDA 510(k)
FDA Class 2
·Hematology
KALESTAD ANA MICROPLATE EIA
FDA 510(k)
FDA Class 2
·Immunology
ACCESS TOTAL T3 ASSAY (MODIFICATION)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS VITAMIN B12 ASSAY (MODIFICATION)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VARIANT II TURBO HbA1c Kit - 2.0
FDA 510(k)
FDA Class 2
·Clinical Chemistry
D-10 Hemoglobin A1c Program
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
FDA 510(k)
FDA Class 2
·Hematology
BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200
FDA 510(k)
FDA Class 2
·Immunology
BIO-RAD D-10 DUAL PROGRAM
FDA 510(k)
FDA Class 2
·Hematology