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.

Multiple urine analyte IVD, kit, colorimetric dipstick, rapid

• 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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