47 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Revogene
FDA 510(k)
FDA Class 2
·Clinical Chemistry
QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
3M INTEGRATED CYCLER (110V) & (220V)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARIES System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARIES System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
revogene
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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
FilmArray 2.0 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ILLUMINA BEADXPRESS SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ePlex Instrument
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FLEXMAP 3D
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry