67 results
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154ms
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Sources: EU EUDAMED, US FDA
Filters
FDA FEI Number: 2967
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ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS ULTRASENSITIVE INSULIN ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0
FDA 510(k)
FDA Class 2
·Hematology
ACCESS LOW LEVEL IGE CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCESS(R) TOTAL T3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LIQUICHEK CARDIAC MARKER CONTROL LT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCESS(R) THYROXINE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS(R) TOTAL IGE ASSAY
FDA 510(k)
FDA Class 2
·Immunology
ACCESS VITAMIN B12 ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCESS HTSH ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
KALLESTEAD TOTAL IGE MICROPLATE KIT
FDA 510(k)
FDA Class 2
·Immunology
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
LIQUICHEK URINE CHEMISTRY CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIQUICHEK BNP CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LYPHOCHEK ASSAYED CHEMISTRY CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry