One+Step UTI

GUDID 08806141303480

The one device included 100 Strips

DFI CO.,LTD

Multiple urine analyte IVD, kit, rapid colorimetric, clinical

• Primary Device ID: 08806141303480
• NIH Device Record Key: c40564e3-1db0-46e8-bea6-d26ff3a2642e
• Commercial Distribution Discontinuation: 2023-10-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: One+Step UTI
• Version Model Number: 3374
• 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: true
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806141303480 [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: 2023-10-23
• Device Publish Date: 2023-10-14

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• 08806141303480 - One+Step UTI: 2023-10-23 The one device included 100 Strips
• 08806141301592 - QTEST K: 2022-10-24 100 strips/ 1 bottle
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