Pixcell Medical Technologies

PMN#

GUDID#

HemoScreen - The HemoScreen is a point-of-care (POC) automated hematology analyzer intended for the enumeration and classification of the following parameters in capillary and venous whole blood (K2EDTA anticoagulated): WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, NEUT%, NEUT#, LYMP%, LYMP#, MONO%, MONO#, EO%, EO#, BASO%, and BASO#. The HemoScreen is for in vitro diagnostic use in clinical laboratories and/or POC settings for adults and children at least 2 years of age.The Extended Range are applicable only to the US and was cleared by the FDA Abbreviated 510(K) Extended ranges K240636

PIXCELL MEDICAL TECHNOLOGIES LTD

2024-09-02

HemoScreen - The HemoScreen is a quantitative automated hematology analyzer intended for in vitro diagnostic point-of-care (POC) use to classify and enumerate the following parameters for capillary and venous whole blood (K2 EDTA anticoagulated) in adults and children at least 2 years of age: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV NEUT%, NEUT#, LYMPH%, LYMP#, MONO%, MONO#, EO%, EO#, BASO%, and BASO#. The HemoScreen analyzer is indicated for use in clinical laboratories, and in POC settings

PIXCELL MEDICAL TECHNOLOGIES LTD

2019-01-14