Lysercell WNR

GUDID 84987562422988

Lysercell WNR is a reagent product to be combined and used with Fluorocell WNR. By hemolyzing red blood cells with Lysercell WNR and by differentiating white blood cells (non-basophil), basophils, and nucleated red blood cells with Lysercell WNR and Fluorocell WNR, the white blood cell count, basophil count, basophil percentage, nucleated red blood cell count, and nucleated red blood cell percentage are analyzed. This reagent is to be used by connecting to an automatic hematology analyzer specified by Sysmex.

SYSMEX CORPORATION

Blood cell lysis reagent IVD
Primary Device ID84987562422988
NIH Device Record Keyc7fdf925-13b6-4431-bebc-eade63068d78
Commercial Distribution StatusIn Commercial Distribution
Brand NameLysercell WNR
Version Model NumberAN577063
Company DUNS690664461
Company NameSYSMEX CORPORATION
Device Count2
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104987562422982 [Primary]
GS184987562422988 [Unit of Use]

FDA Product Code

GGKProducts, Red-Cell Lysing Products

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-08
Device Publish Date2022-11-30

On-Brand Devices [Lysercell WNR]

00664369000516Lysing reagent for hematology analyzers
84987562422988Lysercell WNR is a reagent product to be combined and used with Fluorocell WNR. By hemolyzing re

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