HemoScreen

GUDID 07290016991086

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

Haematological cell analyser IVD
Primary Device ID07290016991086
NIH Device Record Keyac594f96-6b57-4e05-b3e9-1243f56ce58b
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemoScreen
Version Model NumberHemoScreen 200
Company DUNS532623092
Company NamePIXCELL MEDICAL TECHNOLOGIES LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+97249593516
Emailinfo@pixcell-medical.com
Phone+97249593516
Emailinfo@pixcell-medical.com
Phone+97249593516
Emailinfo@pixcell-medical.com
Phone+97249593516
Emailinfo@pixcell-medical.com
Phone+97249593516
Emailinfo@pixcell-medical.com
Phone+97249593516
Emailinfo@pixcell-medical.com
Phone+97249593516
Emailinfo@pixcell-medical.com
Phone+97249593516
Emailinfo@pixcell-medical.com
Phone+97249593516
Emailinfo@pixcell-medical.com
Phone+97249593516
Emailinfo@pixcell-medical.com
Phone+97249593516
Emailinfo@pixcell-medical.com
Phone+97249593516
Emailinfo@pixcell-medical.com
Phone+97249593516
Emailinfo@pixcell-medical.com
Phone+97249593516
Emailinfo@pixcell-medical.com
Phone+97249593516
Emailinfo@pixcell-medical.com
Phone+97249593516
Emailinfo@pixcell-medical.com
Phone+97249593516
Emailinfo@pixcell-medical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016991086 [Primary]

FDA Product Code

GKZCounter, Differential Cell

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-10
Device Publish Date2024-09-02

On-Brand Devices [HemoScreen]

07290016991048A disposable unit used for the collection of the blood sample
07290016991024A self-contained disposable unit in which a single blood sample is prepared and made ready for m
07290016991000The HemoScreen is a quantitative automated hematology analyzer intended for in vitro diagnostic
17290016991076A disposable unit used for the collection of the blood sample
07290016991086The HemoScreen is a point-of-care (POC) automated hematology analyzer intended for the enumerati

Trademark Results [HemoScreen]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEMOSCREEN
HEMOSCREEN
79169295 not registered Dead/Abandoned
PIXCELL MEDICAL TECHNOLOGIES LTD
2015-05-06
HEMOSCREEN
HEMOSCREEN
74229798 not registered Dead/Abandoned
FUJISAWA PHARMACEUTICAL CO., LTD.
1991-12-12

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