GenaCheck® Early Result Pregnancy Test

GUDID 00810143620221

Genabio Diagnostics Inc.

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

• Primary Device ID: 00810143620221
• NIH Device Record Key: 124c978c-29d9-4426-8223-f29aa97f6213
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenaCheck® Early Result Pregnancy Test
• Version Model Number: N/A
• Company DUNS: 118586095
• Company Name: Genabio Diagnostics Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	00810143620221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240643

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, 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: 2025-03-06
• Device Publish Date: 2025-02-26

Devices Manufactured by Genabio Diagnostics Inc.

• 00810143620344 - GenaCheck® COVID-19/Flu A&B Rapid Self-Test: 2025-05-27 GenaCheck® COVID-19/Flu A&B Rapid Self-Test 2T
• 00810143620368 - GenaCheck® COVID-19/Flu A&B Rapid Self-Test: 2025-05-27 GenaCheck® COVID-19/Flu A&B Rapid Self-Test 4T
• 00810143620214 - GenaCheck® FSH At-Home Menopause Test: 2025-03-06
• 00810143620221 - GenaCheck® Early Result Pregnancy Test: 2025-03-06
• 00810143620221 - GenaCheck® Early Result Pregnancy Test: 2025-03-06
• 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