FDA.reportPublic FDA data

ZAPR™

Primary DI
G507ZAPR01000
Brand
ZAPR™
Company
Incell Corporation, LLC
Model
ZAPR0100
Catalog number
ZAPR0100
Device description
Red Blood Cell Lysing Buffer
Published
2023-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
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
G507ZAPR01000PrimaryHIBCC0

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 Volume100Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius32 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-364-1765info@incell.com

Regulatory Flags#

DUNS number
965420953
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G507M400F01000M4:BaseF™M400F0100M400F01002025-08-11
G507M400F05000M4:BaseF™M400F0500M400F05002025-08-11
G507ZEFR01000ZEFR™ZEFR0100ZEFR01002023-10-02
G507ZTMV01000ZTMV™ZTMV0100ZTMV01002023-09-01
G507ZTMV05000ZTMV™ZTMV0500ZTMV05002023-09-01
G507EZNDHS05000EZ-CPZ-ND+2% Hetastarch (Hs)™EZNDHS0500EZNDHS05002023-09-07
G507ZAPR04000ZAPR™ZAPR0400ZAPR04002023-09-06
G507ZSOLF05000ZSol:F™ZSOLF0500ZSOLF05002023-09-06
G507EZCZ01000EZ-CPZ™EZCZ0100EZCZ01002023-09-01
G507EZCZ05000EZ-CPZ™EZCZ0500EZCZ05002023-09-01
G507EZND01000EZ-CPZ-ND™EZND0100EZND01002023-09-01
G507EZND05000EZ-CPZ-ND™EZND0500EZND05002023-09-01
G507M300A01000M3:BaseA™M300A0100M300A01002023-09-01
G507M300A05000M3:BaseA™M300A0500M300A05002023-09-01
G507M300F01000M3:BaseF™M300F0100M300F01002023-09-01
G507M300F05000M3:BaseF™M300F0500M300F05002023-09-01
G507M310A01000M3:10A™M310A0100M310A01002023-09-01
G507M310A05000M3:10A™M310A0500M310A05002023-09-01
G507M3DEC01000M3:DC™M3DEC0100M3DEC01002023-09-01
G507M3DEC05000M3:DC™M3DEC0500M3DEC05002023-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00664369000899LYSERCELL WDF IISYSMEX CORPORATIONGGK2026-04-24
00630414289991Atellica HEMA HGBSiemens Healthcare Diagnostics Inc.GGK2026-02-06
00630414290027Atellica HEMA DiffSiemens Healthcare Diagnostics Inc.GGK2026-02-06
00630414312477Atellica HEMA HGBSiemens Healthcare Diagnostics Inc.GGK2026-02-06
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
EBUHBCCRLYR20CAST® Lysing Reagent BasophilBühlmann Laboratories AGGGK2025-03-04
07350040796405Medonic M51-L1 LyseBoule Medical ABGGK2024-10-04
07350040796412Medonic M51-L2 LyseBoule Medical ABGGK2024-10-04
07350040796436Swelab Lumi-L1 LyseBoule Medical ABGGK2024-10-04
07350040796443Swelab Lumi-L2 LyseBoule Medical ABGGK2024-10-04
03610230008157NUCEDIFF (1L)HORIBA ABX SASGGK2024-05-30
07540207107490EasySep™ Red Blood Cell Lysis Buffer, 10X ConcentrateStemcell Technologies Canada IncGGK2024-02-08
15099590744854DxHBeckman Coulter, Inc.GGK2023-12-15
00380740136963AlinityAbbott Ireland DiagnosticsGGK2023-11-16
G507ZAPR04000ZAPR™Incell Corporation, LLCGGK2023-09-06
05999883586167Diatro•Diff-5PDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagGGK2023-04-24
05999883586105Diatro•Lyse-DIFFDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagGGK2023-04-24
15999883586164Diatro•Diff-5PDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagGGK2023-04-24
04987562422975SULFOLYSERSYSMEX CORPORATIONGGK2022-11-30
04987562422982Lysercell WNRSYSMEX CORPORATIONGGK2022-11-30