PIXCELL MEDICAL TECHNOLOGIES LTD

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Counter, Differential Cell (GKZ) (4) Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use (LXG) (1)

Premarket Exempt

No Yes

Clear

HemoScreen - 07290016991000 Catalog Number :

Device Description : The HemoScreen is a quantitative automated hematology analyzer intended for in v 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

Device Class : 2

Duns Number: 532623092

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

HemoScreen - 07290016991017 Catalog Number : BC-FA-00103

Device Description : A self-contained disposable unit in which a single blood sample is prepared and A self-contained disposable unit in which a single blood sample is prepared and made ready for measurement and CBC analysis

Device Class :

Duns Number: 532623092

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

HemoScreen - 07290016991048 Catalog Number : BC-FA-00201

Device Description : A disposable unit used for the collection of the blood sample

Device Class :

Duns Number: 532623092

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 10

HemoCup - 07290016991062 Catalog Number :

Device Description : A disposable unit used for dispensing blood from a test tube.

Device Class :

Duns Number: 532623092

Premarket Exempt : Yes

Product Code : LXG

Prescription Use : No

Device Count : 100

HemoScreen - 07290016991079 Catalog Number : BC-MA-00100

Device Description : A disposable unit used for the collection of the blood sample

Device Class :

Duns Number: 532623092

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

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