505 results · 48ms · Sources: EU EUDAMED, US FDA

DYNATECH SPD 3000, #002-900-0000

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Alere i Instrument, Alere i Influenza A & B, Alere i Strep A

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Revogene

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ROTOR-GENE Q MDX

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BD VIPER LT SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Revogene

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

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