M-53LH LYSE 105-011735-00

GUDID 06944904093161

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Blood cell lysis reagent IVD

• Primary Device ID: 06944904093161
• NIH Device Record Key: 666cbab4-931f-43f3-94a6-e188095c1ef7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M-53LH LYSE
• Version Model Number: M-53LH
• Catalog Number: 105-011735-00
• Company DUNS: 654671304
• Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944904093161 [Primary]

FDA Product Code

• GGK: Products, Red-Cell Lysing Products

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-30
• Device Publish Date: 2026-01-22

On-Brand Devices [M-53LH LYSE]

• 06944904093161: M-53LH
• 06944904093154: M-53LH