FDA.reportPublic FDA data

Hemolysis and Wash Solution

Primary DI
00853931008030
Brand
Hemolysis and Wash Solution
Company
TOSOH BIOSCIENCE, INC.
Model
018431US
Device description
Red Cell Lysing Reagent
Published
2018-04-23
Public version status
Update
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
00853931008030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853931008030008539310080308539310080300853931008030

GMDN Terms#

Term, Definition table
TermDefinition
Buffered wash solution IVD, automated/semi-automated systemA buffered wash solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument during the processing, staining and/or testing of clinical laboratory specimens to neutralize/wash/rinse away excess reactants and/or to function as a wetting agent.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
614-317-1916kimberly.harmeson@tosoh.com

Regulatory Flags#

DUNS number
607696440
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
00853931008009Tosoh Automated Glycohemoglobin Analyzer HLC-723G8RHLC-723G8R021560R2018-03-26
00853931008016Glycated Hemoglobin (HbA1C) Analyzer IVDG8-90SLR021561R2018-04-04
00853931008023Glycated Hemoglobin (HbA1C) Analyser IVD, 290 Loader, RemanufacturedG8-290SLR021562R2018-04-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
G507ZAPR01000ZAPR™Incell Corporation, LLCGGK2023-09-06
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