Frida

GUDID 10810028774084

Early Detection Pregnancy Tests

Fridababy, LLC

Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing

• Primary Device ID: 10810028774084
• NIH Device Record Key: 9be13beb-22cc-4166-9923-8a54915300d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Frida
• Version Model Number: 500001287
• Company DUNS: 783729598
• Company Name: Fridababy, LLC
• Device Count: 2
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810028774087 [Unit of Use]
GS1	10810028774084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172257

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: 2024-09-20
• Device Publish Date: 2024-09-12

On-Brand Devices [Frida]

• 10810028774084: Early Detection Pregnancy Tests
• 00810028776166: Fertility Friendly Lubricant