GenaCheck®PdG At-Home Ovulation Confirmation Test

GUDID 00810143620207

Genabio Diagnostics Inc.

Multiple female fertility marker IVD, kit, rapid ICT, clinical

• Primary Device ID: 00810143620207
• NIH Device Record Key: c284e07a-7e83-4f58-8b26-37fc7b83d10e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenaCheck®PdG At-Home Ovulation Confirmation Test
• Version Model Number: N/A
• Company DUNS: 118586095
• Company Name: Genabio Diagnostics Inc.
• Device Count: 5
• 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	00810143620207 [Primary]
GS1	81014362020700 [Unit of Use]

FDA Product Code

• QKE: Immunoassay, Pregnanediol Glucuronide, Over The Counter

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: 2025-01-21
• Device Publish Date: 2025-01-13

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