UCARE 11 Stick

GUDID 08806125680279

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

YD Diagnostics CORP.

Multiple urine analyte IVD, kit, colorimetric dipstick, rapid

• Primary Device ID: 08806125680279
• NIH Device Record Key: 7def080a-0bcd-41e8-91c2-1b6cf7f44f58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UCARE 11 Stick
• Version Model Number: P411
• 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	08806125680279 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952307

FDA Product Code

• CDM: Diazonium Colorimetry, Urobilinogen (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: 2017-07-28

On-Brand Devices [UCARE 11 Stick]

• 08806125680286: Urinalysis dip and read strips for urine analyzer. Test for Blood, Bilirubin, Urobilinogen, Keto
• 08806125680279: Urinalysis dip and read strips for urine analyzer. Test for Blood, Bilirubin, Urobilinogen, Keto