2,207 results · 45ms · Sources: EU EUDAMED, US FDA

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

APPLIED BIOSYSTEMS 7500 FAST DX

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VANTERA CLINICAL ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DADE DISP. DISPENSING-SPREADING PIPETS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

PRE-CALIBRATED PIPETTES

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MICROPITETTE

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LABORATORY EXPENDABLE PRODUCTS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry