954 results
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45ms
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Sources: EU EUDAMED, US FDA
Helix Laboratory Platform
FDA 510(k)
FDA Class 2
·Medical Genetics
Whole Exome Sequencing Constituent Device
FDA classification
FDA Class 2
·Whole Exome Sequencing Constituent Device
Access BR Monitor
FDA registration
DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI·2 products·🇹🇷 Türkiye
Access BR Monitor (P/N: 387620)
FDA registration
BECKMAN COULTER, INC.·2 products·🇺🇸 United States
PSA
FDA registration
IMMUNOCENTRIX CORPORATION·1 product·🇺🇸 United States
VITROS Immunodiagnostic Products CEA Calibrators
FDA registration
Ortho-Clinical Diagnostics·1 product·🇬🇧 United Kingdom
Total PSA Elecsys cobas e 100
FDA registration
ROCHE DIAGNOSTICS GMBH·2 products·🇩🇪 Germany
Alinity i CA 19-9XR Controls
FDA registration
Fujirebio Diagnostics, Inc.·1 product·🇺🇸 United States
OIU / Test, epithelial ovarian tumor associated antigen (he4)
FDA registration
MONOCENT INC.·1 product·🇺🇸 United States
CL AIA-PACK Tg
FDA registration
TOSOH CORP.·1 product·🇯🇵 Japan
CELLSEARCH Circulating Tumor Cell Kit (Epithelial)
FDA registration
SIGMA-ALDRICH MANUFACTURING, LLC·1 product·🇺🇸 United States
ACCESS CEA
FDA registration
BIO-RAD·1 product·🇫🇷 France
IMMULITE
FDA registration
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED·1 product·🇬🇧 United Kingdom
CL0816 Free Prostate- specific antigen CLIA kit
FDA registration
EPITOPE DIAGNOSTICS, INC.·1 product·🇺🇸 United States
Access CEA Diluent (P/N: 33206)
FDA registration
BECKMAN COULTER, INC.·1 product·🇺🇸 United States
VITROS CA 125 II Calibrator
FDA registration
Ortho-Clinical Diagnostics European Support Center·1 product·🇫🇷 France
IMMULITE 2000 PSA
FDA registration
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED·2 products·🇬🇧 United Kingdom
AIA-PACK 27.29 Calibrator Set,AIA-PACK 27.29 Sample diluting solution
FDA registration
TOSOH AIA, INC.·1 product·🇯🇵 Japan
VITROS Immunodiagnostic Products CA 19-9 Reagent Pack
FDA registration
Ortho Clinical Diagnostics·1 product·🇸🇬 Singapore
Atellica IM CA 15-3 Calibrator (CA15-3 CAL)
FDA registration
Siemens Healthcare Diagnostics Inc.·1 product·🇺🇸 United States