FDA.reportPublic FDA data

M-30CFL LYSE

Primary DI
06936415908812
Brand
M-30CFL LYSE
Company
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Model
M-30CFL
Catalog number
105-006210-00
Published
2026-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
06936415908812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936415908812069364159088126936415908812

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
654671304
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06903053063852Diagnostic Ultrasound SystemImagyn A20 Exp2026-10-31
06903053063869Diagnostic Ultrasound SystemNuewa A20Q2026-10-31
06903053063876Diagnostic Ultrasound SystemNuewa A Lumi2026-10-31
06903053063883Diagnostic Ultrasound SystemNuewa A18W2026-10-31
06903053063890Diagnostic Ultrasound SystemNuewa A20 Exp2026-10-31
06903053063906Diagnostic Ultrasound SystemNuewa A20 Plus2026-10-31
06903053063913Diagnostic Ultrasound SystemNuewa A20 Elite2026-10-31
06903053063937Diagnostic Ultrasound SystemNuewa AR2026-10-31
06903053063944Diagnostic Ultrasound SystemNuewa A202026-10-31
06903053063951Diagnostic Ultrasound SystemNuewa A MS2026-10-31
06903053063968Diagnostic Ultrasound SystemImagyn A20S2026-10-31
06903053063975Diagnostic Ultrasound SystemNuewa A20S2026-10-31
06903053063982Diagnostic Ultrasound SystemNuewa A20 Premium2026-10-31
06903053064002Diagnostic Ultrasound SystemNuewa A20W2026-10-31
06903053064019Diagnostic Ultrasound SystemNuewa A20 Pro2026-10-31
06903053064026Diagnostic Ultrasound SystemNuewa A MV2026-10-31
06903053064033Diagnostic Ultrasound SystemImagyn A202026-10-31
06903053064040Diagnostic Ultrasound SystemNuewa A20T2026-10-31
06903053064057Diagnostic Ultrasound SystemNuewa A Elite2026-10-31
06903053064064Diagnostic Ultrasound SystemImagyn A20T2026-10-31

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
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 LABORATORIESGGK2023-11-16
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
04987562422982Lysercell WNRSYSMEX CORPORATIONGGK2022-11-30