Visby Medical Women's Sexual Health Test

GUDID 00810031720088

Visby Medical, Inc.

Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical

• Primary Device ID: 00810031720088
• NIH Device Record Key: 4a1c8585-5f26-43c0-9c72-a9c9d4d8e293
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visby Medical Women's Sexual Health Test
• Version Model Number: PS-400145
• Company DUNS: 933894748
• Company Name: Visby Medical, 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: true
• Manufacturing Date: true
• 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	00810031720088 [Primary]

FDA Product Code

• SEA: Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

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: 2025-08-15
• Device Publish Date: 2025-08-07