GenaCheck®LH At-Home Ovulation Prediction Test

GUDID 00810143620191

Genabio Diagnostics Inc.

Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical

• Primary Device ID: 00810143620191
• NIH Device Record Key: e527b74b-8dcc-46dc-b5b7-9af4aa8b4698
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenaCheck®LH At-Home Ovulation Prediction Test
• Version Model Number: N/A
• Company DUNS: 118586095
• Company Name: Genabio Diagnostics Inc.
• Device Count: 10
• 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	00810143620191 [Primary]
GS1	81014362019100 [Unit of Use]

FDA Product Code

• NGE: Test, Luteinizing Hormone (Lh), 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

Devices Manufactured by Genabio Diagnostics Inc.

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• 00810143620115 - GenaCheck® Nitrile Powder Free Examination Glove: 2025-01-21
• 00810143620139 - GenaCheck® Nitrile Powder Free Examination Glove: 2025-01-21
• 00810143620146 - GenaCheck® Nitrile Powder Free Examination Glove: 2025-01-21
• 00810143620153 - GenaCheck® Nitrile Powder Free Examination Glove: 2025-01-21
• 00810143620184 - Genabio COVID-19 Rapid Self-Test Kit: 2025-01-21
• 00810143620191 - GenaCheck®LH At-Home Ovulation Prediction Test: 2025-01-21
• 00810143620191 - GenaCheck®LH At-Home Ovulation Prediction Test: 2025-01-21