29 results
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71ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 1
×
ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIQUICHEK TORCH PLUS IGM CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCESS PROLACTIN
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCESS PROLACTIN ASSAY (MODIFICATION)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
ACCESS ULTRASENSITIVE INSULIN ASSAY
FDA 510(k)
FDA Class 1
·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
LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK
FDA 510(k)
FDA Class 1
·Clinical Toxicology
KALLESTAD ROTAVIRUS MICROPLATE
FDA 510(k)
FDA Class 1
·Microbiology
LIQUICHEK CARDIAC MARKER CONTROL LT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EXPRESSO CARTRIDGE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)
FDA 510(k)
FDA Class 1
·Clinical Toxicology
LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK
FDA 510(k)
FDA Class 1
·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