URiSCAN 10 SGL strip

GUDID 08806125680019

Urinalysis dip and read strips for visual and URiSCAN urine analyzer. Test for Blood, Bilirubin, Urobilinogen, Ketones(Acetoacetic Acid), Protein, Nitrite, Glucose, pH, SG(Specific Gravity) and Leucocytes in urine.

YD Diagnostics CORP.

Multiple urine analyte IVD, kit, colorimetric dipstick, rapid

• Primary Device ID: 08806125680019
• NIH Device Record Key: bc6732bd-2ca4-480e-a34f-d9f11a3e12b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: URiSCAN 10 SGL strip
• Version Model Number: U391
• 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	08806125680019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952307

FDA Product Code

• JIL: Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

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

On-Brand Devices [URiSCAN 10 SGL strip]

• 08806125680217: Urinalysis dip and read strips for visual and URiSCAN urine analyzer. Test for Leucocytes, Nitri
• 08806125680019: Urinalysis dip and read strips for visual and URiSCAN urine analyzer. Test for Blood, Bilirubin,