GenaCheck Vaginal pH Screening Test

GUDID 00810143620016

Genabio Diagnostics Inc.

Vaginal pH screening IVD, kit, rapid colorimetric, self-testing

• Primary Device ID: 00810143620016
• NIH Device Record Key: 5830ba69-a08a-4401-8ff4-dd187b77a895
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenaCheck Vaginal pH Screening Test
• Version Model Number: RA9-E02303
• Company DUNS: 118586095
• Company Name: Genabio Diagnostics Inc.
• Device Count: 3
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810143620016 [Primary]
GS1	00810143620078 [Unit of Use]

FDA Product Code

• LNW: Paper, Obstetric Ph

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: 2023-08-14
• Device Publish Date: 2023-08-04

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