M-5LEO(I) Lyse 105-011724-00

GUDID 06944904093116

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Blood cell lysis reagent IVD
Primary Device ID06944904093116
NIH Device Record Key913c959c-0c44-4ef9-99f4-55ca221861fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameM-5LEO(I) Lyse
Version Model NumberM-5LEO(I)
Catalog Number105-011724-00
Company DUNS654671304
Company NameShenzhen Mindray Bio-Medical Electronics Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106944904093116 [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 Date2026-01-30
Device Publish Date2026-01-22

On-Brand Devices [M-5LEO(I) Lyse]

06944904093123M-5LEO(I)
06944904093116M-5LEO(I)

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