One+Step Uric Acid

GUDID 08806141303077

DFI CO.,LTD

Multiple urine analyte IVD, kit, colorimetric dipstick, rapid

• Primary Device ID: 08806141303077
• NIH Device Record Key: 11f80303-ec01-4e69-b98f-5bb9637109d8
• Commercial Distribution Discontinuation: 2022-10-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: One+Step Uric Acid
• Version Model Number: 31H0P
• Company DUNS: 688779180
• Company Name: DFI 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806141303077 [Primary]

FDA Product Code

• KNK: Acid, Uric, Uricase (Colorimetric)

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: 2022-10-11
• Device Publish Date: 2022-10-03

On-Brand Devices [One+Step Uric Acid]

• 08806141303077: 31H0P
• 08806141304029: The one device that has DI number included 5 strips
• 08806141304036: One pack included 10 pouch
• 08806141304043: One packing included 5 pouch.