346 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
×
AmplideX Fragile X Dx & Carrier Screen Kit
FDA 510(k)
FDA Class 2
·Immunology
Invitae Common Hereditary Cancers Panel
FDA 510(k)
FDA Class 2
·Pathology
Adaptive Biotechnologies clonoSEQ Assay
FDA 510(k)
FDA Class 2
·Pathology
VENTANA CD30 (Ber-H2) RxDx Assay
FDA 510(k)
FDA Class 2
·Immunology
xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR
FDA 510(k)
FDA Class 2
·Immunology
Parsortix PC1 Device
FDA 510(k)
FDA Class 2
·Immunology
GenetiSure Dx Postnatal Assay
FDA 510(k)
FDA Class 2
·Immunology
xTAG Cystic Fibrosis 39 Kit v2
FDA 510(k)
FDA Class 2
·Immunology
PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES
FDA 510(k)
FDA Class 2
·Hematology
HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA
FDA 510(k)
FDA Class 2
·Hematology
IL TEST PROCLOT ASSAY STYSTEM
FDA 510(k)
FDA Class 2
·Hematology
GTI-FVIII INHIBITOR ASSAY
FDA 510(k)
FDA Class 2
·Hematology
REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT
FDA 510(k)
FDA Class 2
·Hematology
CRYOCHECK CLOT S
FDA 510(k)
FDA Class 2
·Hematology
PROTEIN S CONTROL PLASMA
FDA 510(k)
FDA Class 2
·Hematology
HELENA FACTOR IX DEFICIENT SUBSTRATE
FDA 510(k)
FDA Class 2
·Hematology
INNOVANCE Free PS Ag
FDA 510(k)
FDA Class 2
·Hematology
FACTOR XII DEFICIENT PLASMA B12D
FDA 510(k)
FDA Class 2
·Hematology
COATEST PROTEIN C
FDA 510(k)
FDA Class 2
·Hematology
VISULIZE FACTOR IX ANTIGEN KIT
FDA 510(k)
FDA Class 2
·Hematology