442 results · 103ms · Sources: EU EUDAMED, US FDA

Atellica HEMA 520 OT

Device
EU IVDR · Eu Ivd Class B ·HORIBA ABX SAS·On the market·19 countries

Atellica HEMA 520 CT

Device
EU IVDR · Eu Ivd Class B ·HORIBA ABX SAS·On the market·19 countries

Atellica HEMA 530

Device
EU IVDR · Eu Ivd Class B ·HORIBA ABX SAS·On the market·19 countries

Yumizen G405

Device
EU IVDR · Eu Ivd Class A ·HORIBA ABX SAS·On the market

Yumizen H500E OT

Device
EU IVDR · Eu Ivd Class B ·HORIBA ABX SAS·On the market·32 countries

Yumizen H500E CT

Device
EU IVDR · Eu Ivd Class B ·HORIBA ABX SAS·On the market·32 countries

Yumizen H550E

Device
EU IVDR · Eu Ivd Class B ·HORIBA ABX SAS·On the market·32 countries

ESRtrol

Device
EU IVDR · Eu Ivd Class B ·HORIBA ABX SAS·On the market·32 countries

Yumizen G SORB

Device
EU IVDR · Eu Ivd Class A ·HORIBA ABX SAS·On the market

ABX Pentra Deproteinizer CP

Device
EU IVDR · Eu Ivd Class A ·HORIBA ABX SAS·On the market

PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Yumizen C1200 CRP

FDA 510(k)
FDA Class 2 ·Immunology

Yumizen H2500

FDA 510(k)
FDA Class 2 ·Hematology

ABX MICROS ES 60 OT and ABX MICROS ES 60 CT

FDA 510(k)
FDA Class 2 ·Hematology

ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)

FDA 510(k)
FDA Class 2 ·Hematology

Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor

FDA 510(k)
FDA Class 2 ·Immunology

PENTRA XLR

FDA 510(k)
FDA Class 2 ·Hematology

ABX PENTRA MICRO ALB CONTROL L/H

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Yumizen C1200 CRP

FDA 510(k)
FDA Class 2 ·Immunology