URiSCAN 2 ACR strip

GUDID 08806125680224

Urinalysis dip and read strips for URiSCAN urine analyzer. Test for Microalbumin and Creatinine in urine.

YD Diagnostics CORP.

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• Primary Device ID: 08806125680224
• NIH Device Record Key: 739cc659-36d1-4236-83a2-d1294ec84b83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: URiSCAN 2 ACR strip
• Version Model Number: U643
• Company DUNS: 687769737
• Company Name: YD Diagnostics CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	08806125680224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141874

FDA Product Code

• JIR: Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-12-22
• Device Publish Date: 2016-08-05

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