51 results
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152ms
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Sources: EU EUDAMED, US FDA
Filters
FDA FEI Number: 3000308930
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ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS LOW LEVEL IGE CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)
FDA 510(k)
FDA Class 1
·Clinical Toxicology
ACCESS(R) TOTAL T3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK
FDA 510(k)
FDA Class 1
·Clinical Toxicology
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
LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)
FDA 510(k)
FDA Class 1
·Clinical Toxicology
ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS CORTISOL ASSAY (MODIFICATION)
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
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
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05
FDA 510(k)
FDA Class 1
·Clinical Chemistry