59 results
·
82ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
×
Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
FDA 510(k)
FDA Class 2
·Hematology
ACCESS RUBELLA IGG
FDA 510(k)
FDA Class 2
·Microbiology
ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS SPECIFIC IGE ASSAY
FDA 510(k)
FDA Class 2
·Immunology
VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0
FDA 510(k)
FDA Class 2
·Hematology
ACCESS(R) TOTAL T3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BIOPLEX 2200 TORC IGG
FDA 510(k)
FDA Class 2
·Microbiology
ACCESS(R) THYROXINE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS FERRITIN ASSAY
FDA 510(k)
FDA Class 2
·Immunology
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
ACCESS CORTISOL ASSAY (MODIFICATION)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS HTSH ASSAY
FDA 510(k)
FDA Class 2
·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
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