62 results
·
159ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA FEI Number: 1219913
×
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·BIO-RAD MONOLISA ANTI-HBC EIA
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 RUBELLA IGG
FDA 510(k)
FDA Class 2
·Microbiology
ACCESS PROLACTIN ASSAY (MODIFICATION)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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
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 CK-MB REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS(R) CORTISOL REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry