67 results
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153ms
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Sources: EU EUDAMED, US FDA
Filters
FDA FEI Number: 2967
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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
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 TOTAL BHCG ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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 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 PROGESTERONE ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM
FDA 510(k)
FDA Class 2
·Hematology
ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
D-10 HEMOGLOBIN A1C
FDA 510(k)
FDA Class 2
·Hematology
ACCESS TOTAL BHCG ASSAY (MODIFICATION)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
D-100 HbA1c, D-100 HbA1c Calibrator Pack
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU
FDA 510(k)
FDA Class 2
·Hematology