10,000 results
·
188ms
·
Sources: EU EUDAMED, US FDA
Prosigna(R) Breast Cancer Prognostic Gene Signature Assay
FDA registration
NanoString, a Bruker Company·2 products·🇺🇸 United States
FilmArray NGDS Warrior Panel
FDA registration
BioFire Defense, LLC·2 products·🇺🇸 United States
Aptima CV/TV assay
FDA registration
Hologic, Inc.·2 products·🇺🇸 United States
DASH® Negative Control
FDA registration
Nuclein, LLC·2 products·🇺🇸 United States
LIAISON PLEX Gram-Negative Blood Culture Assay
FDA registration
Luminex Corporation·2 products·🇺🇸 United States
T2Dx Instrument
FDA registration
T2 BIOSYSTEMS, INC.·2 products·🇺🇸 United States
Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)
FDA registration
Luminex Corporation·2 products·🇺🇸 United States
T2Bacteria Panel
FDA registration
T2 BIOSYSTEMS, INC.·2 products·🇺🇸 United States
Prosigna(R) Breast Cancer Prognostic Gene Signature Assay
FDA registration
Veracyte, Inc.·2 products·🇺🇸 United States
DASH® Negative Control
FDA registration
Nuclein, LLC·2 products·🇺🇸 United States
LIAISON PLEX® Gram-Positive Blood Culture Assay
FDA registration
Luminex Corporation·2 products·🇺🇸 United States
GENEXPERT DX SYSTEM
FDA registration
Sanmina-SCI Systems (Malaysia) Sdn Bhd·2 products·🇲🇾 Malaysia
GENEXPERT DX SYSTEM
FDA registration
Sanmina·2 products·🇺🇸 United States
Aptima SARS-CoV-2 Assay
FDA registration
Hologic, Inc.·2 products·🇺🇸 United States
Xpert Xpress MVP
FDA registration
Cepheid·2 products·🇺🇸 United States
INFINITI CYP2C19 Assay
FDA registration
AUTOGENOMICS, INCORPORATED·2 products·🇺🇸 United States
VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LUMINEX LX 100/200 INSTRUMENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ESENSOR WARFARIN SENSITIVITY SALIVA TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry