GenaCheck Rapid Self-Test Kit For Urinary Tract Infections

GUDID 10810143620006

Genabio Diagnostics Inc.

Multiple urine analyte IVD, kit, rapid colorimetric, clinical

• Primary Device ID: 10810143620006
• NIH Device Record Key: 787c5ee9-39f6-4678-a622-d7ff3f901c21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenaCheck Rapid Self-Test Kit For Urinary Tract Infections
• Version Model Number: RA9-E01802
• Company DUNS: 118586095
• Company Name: Genabio Diagnostics Inc.
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810143620009 [Primary]
GS1	10810143620006 [Unit of Use]

FDA Product Code

• JMT: Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)

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: 2023-10-16
• Device Publish Date: 2023-10-06

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