262 results · 20ms · Sources: EU EUDAMED, US FDA

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Manufacturer
🇫🇷 France

HORIBA ABX SAS

Manufacturer
🇫🇷 France·57 Basic UDI-DIs·86 Devices

HORIBA ABX SAS

FDA registration
HORIBA ABX SAS·63 products·🇫🇷 France

ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ABX ERYTROL

FDA 510(k)
FDA Class 2 ·Hematology

Yumizen G800h

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

Yumizen G850h

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

BFTROL

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

Yumizen H2500 (Yumizen SPS connectable)

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

Yumizen H2500

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

Yumizen H1500 (Yumizen SPS connectable)

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

Yumizen H1500

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

ABX Minilyse LMG 1L

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

Yumizen P8000

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

ISE Module Complete Pentra C400

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

Pentra C400 ISE

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