DiaSpect Control Pack HBT1

FDA UDI

DiaSpect Medical GmbH·04048534001557·For the verification of the precision and accur...

DiaSpect Control Pack HBT3

FDA UDI

DiaSpect Medical GmbH·04048534001571·For the verification of the precision and accur...

DiaSpect Control Pack HBT4

FDA UDI

DiaSpect Medical GmbH·04048534001588·For the verification of the precision and accur...

KF 300 D/T

Device

EU MDR · Eu Md Class 2a ·Kluge & Fielitz GmbH·On the market·7 countries

KF 300 XL/D

Device

EU MDR · Eu Md Class 2a ·Kluge & Fielitz GmbH·On the market·7 countries

KF 300 XL/T

Device

EU MDR · Eu Md Class 2a ·Kluge & Fielitz GmbH·On the market·7 countries

KF 200 XL/D

Device

EU MDR · Eu Md Class 2a ·Kluge & Fielitz GmbH·On the market·7 countries

KF 900 XL/D

Device

EU MDR · Eu Md Class 2a ·Kluge & Fielitz GmbH·On the market·4 countries

STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS

FDA 510(k)

FDA Class 2 ·Hematology

MARATHON 6K GENERAL-PURPOSE CENTRIFUGE

FDA 510(k)

FDA Class 2 ·Hematology

GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)

FDA 510(k)

FDA Class 2 ·Hematology

HICHEM ALP/AMP REAGENT KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE M ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

MICROHEMATOCRIT CENTRIFUGE

FDA 510(k)

FDA Class 2 ·Hematology

MICROSPIN 24

FDA 510(k)

FDA Class 2 ·Hematology

HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CHEMPRO 1000(TM)

FDA 510(k)

FDA Class 2 ·Hematology

CRIT-SCAN II MONITOR

FDA 510(k)

FDA Class 2 ·Hematology

MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE

FDA 510(k)

FDA Class 2 ·Hematology

STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS

FDA 510(k)

FDA Class 2 ·Hematology