ONE+Step Uric Acid

GUDID 08806141304036

One pack included 10 pouch

DFI CO.,LTD

Multiple urine analyte IVD, kit, rapid colorimetric, clinical

• Primary Device ID: 08806141304036
• NIH Device Record Key: 564de680-d328-435d-9693-8b3fd80b31d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE+Step Uric Acid
• Version Model Number: 31H1
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806141304036 [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: 2025-09-11
• Device Publish Date: 2025-09-03

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.