Welcheck URINARY TRACT INFECTION TEST UTI-1021

GUDID 06974246461663

Safecare Biotech (Hangzhou) Co., Ltd.

Multiple urine analyte IVD, kit, rapid colorimetric, clinical

• Primary Device ID: 06974246461663
• NIH Device Record Key: 2d3bb3b5-8619-4dc5-aca6-298b5112f9c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Welcheck URINARY TRACT INFECTION TEST
• Version Model Number: 3 tests
• Catalog Number: UTI-1021
• Company DUNS: 544349634
• Company Name: Safecare Biotech (Hangzhou) 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974246461663 [Primary]

FDA Product Code

• LJX: Test, Urine Leukocyte

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: 2024-10-24
• Device Publish Date: 2024-10-16

On-Brand Devices [Welcheck URINARY TRACT INFECTION TEST]

• 06974246461670: 7 tests
• 06974246461663: 3 tests