LYSERCELL WDF

GUDID 00664369000509

Lysing reagent for hematology analyzers

SYSMEX CORPORATION

Blood cell lysis reagent IVD
Primary Device ID00664369000509
NIH Device Record Key2ef2c218-ce2c-4329-9039-3430baf6e11b
Commercial Distribution StatusIn Commercial Distribution
Brand NameLYSERCELL WDF
Version Model NumberZA900001
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 Usetrue
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)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com

Device Dimensions

Total Volume5 Liter
Total Volume5 Liter
Total Volume5 Liter
Total Volume5 Liter
Total Volume5 Liter
Total Volume5 Liter
Total Volume5 Liter
Total Volume5 Liter
Total Volume5 Liter
Total Volume5 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
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
GS100664369000509 [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 Date2022-11-14
Device Publish Date2022-11-04

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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