LYSERCELL WDF

GUDID 04987562499809

Lysercell WDF is a reagent product to be combined and used with Fluorocell WDF

SYSMEX CORPORATION

Blood cell lysis reagent IVD
Primary Device ID04987562499809
NIH Device Record Keyf86b474a-b84f-4acf-8192-5e06c89493ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameLYSERCELL WDF
Version Model NumberAZ124801
Company DUNS690664461
Company NameSYSMEX CORPORATION
Device Count1
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

Device Dimensions

Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter

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
GS104987562499809 [Primary]

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 WDF]

00664369000509Lysing reagent for hematology analyzers
04987562499809Lysercell WDF is a reagent product to be combined and used with Fluorocell WDF
14987562432322Lysercell WDF is a reagent product to be combined and used with Fluorocell WDF.
14987562422996Lysercell WDF is a reagent product to be combined and used with Fluorocell WDF. By hemolyzing re

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