LYZ

GUDID 16976122480000

Changchun Lyz Technology Co., Ltd.

Multiple urine analyte IVD, kit, rapid colorimetric, self-testing

• Primary Device ID: 16976122480000
• NIH Device Record Key: cadfc57f-ea18-4731-a2f8-68236c4053ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LYZ
• Version Model Number: 100 strips 1 bottle
• Company DUNS: 730268325
• Company Name: Changchun Lyz Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	16976122480000 [Primary]

FDA Product Code

• JIN: Nitroprusside, Ketones (Urinary, Non-Quant.)

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: 2023-04-05
• Device Publish Date: 2023-03-28