Easy@Home Urinary Tract Infection Test Strips (20 Pack) EZU-101-20

GUDID 00810038633473

Easy@Home Urinary Tract Infection Test Strips (20 Pack)

EASY HEALTHCARE CORPORATION

Multiple urinary tract infection-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00810038633473
• NIH Device Record Key: 6b35e319-814a-4413-8d9d-469756c6dc1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Urinary Tract Infection Test Strips (20 Pack)
• Version Model Number: EZU-101
• Catalog Number: EZU-101-20
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810038633473 [Primary]
GS1	30810038633474 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063295

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: 2022-02-25
• Device Publish Date: 2022-02-17

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