FDA.reportPublic FDA data

LYSERCELL WDF II

Primary DI
00664369000899
Brand
LYSERCELL WDF II
Company
SYSMEX CORPORATION
Model
CY754019
Catalog number
ZA900014
Device description
Lysing reagent for hematology analyzers
Published
2026-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GGKProducts, Red-Cell Lysing Products

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGKProducts, Red-Cell Lysing ProductsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00664369000899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00664369000899006643690008996643690008990664369000899

GMDN Terms#

Term, Definition table
TermDefinition
Blood cell lysis reagent IVDA substance or reactant intended to be used alone or in combination with other IVDs to disrupt the cell membrane of blood cells [red blood cells (RBCs), white blood cells (WBCs) and/or platelets] to release cytoplasmic contents in preparation for further analysis.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Liter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze. Avoid direct sunlight and dust.
Storage Environment Temperature2 Degrees Celsius35 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(888)879-7639crc@sysmex.com

Regulatory Flags#

DUNS number
690664461
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987562516797CA CAL S014-1271-42024-02-22
04987562205936CA CAL S014127142017-10-06
04987562408528UF II CONTROL064041152022-11-30
04987562499700Automated Blood Coagulation Analyzer CN-3000CL971029CL9710292025-12-19
04987562518616Automated Blood Coagulation Analyzer CN-3000BN343315CL9710292025-12-19
14987562460264EIGHTCHECK-3WP140-3004-02016-08-05
14987562460387RANGE CHECK X lll2189812016-08-05
14987562460608plt-CHECK200-4004-02017-10-06
14987562460615plt-CHECK200-4004-12017-10-06
04987562518654Automated Blood Coagulation Analyzer CS-5100CU624138BY9907572024-02-22
04987562518661Automated Blood Coagulation Analyzer CS-2500AG528355BV9817982024-02-22
04987562518678Automated Blood Coagulation Analyzer CA-600 series CA-620CM217273BR1426262024-02-22
04987562518685Automated Blood Coagulation Analyzer CA-600 series CA-660CA174898CK9782892024-02-22
04987562425426Automated Blood Coagulation Analyzer CS-5100BY990757BY9907572016-08-05
04987562425686Automated Blood Coagulation Analyzer CA-600 series CA-620BR142626BR1426262016-08-04
04987562425716Automated Blood Coagulation Analyzer CA-600 series CA-660CK978289CK9782892016-08-05
04987562433735Automated Blood Coagulation Analyzer CS-2500BV981798BV9817982016-09-16
04987562499687Automated Blood Coagulation Analyzer CN-6000CV339763CV3397632025-08-22
04987562518630Automated Blood Coagulation Analyzer CN-6000AX801645CV3397632025-08-22
04987562488506UDM (Urinalysis Data Manager)1.XAB3645032025-03-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00630414290003Atellica HEMA BasoSiemens Healthcare Diagnostics Inc.GGK2026-02-06
00630414312491Atellica HEMA DiffSiemens Healthcare Diagnostics Inc.GGK2026-02-06
06903053010641M-30CFL LYSEShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06936415908805M-30CFL LYSEShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06936415908812M-30CFL LYSEShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06944904093116M-5LEO(I) LyseShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06944904093123M-5LEO(I) LyseShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06944904093130M-5LEO(II) LyseShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06944904093147M-5LEO(II) LyseShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06944904093154M-53LH LYSEShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06944904093161M-53LH LYSEShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
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