BEB

GUDID 00860011389224

BEB hCG Pregnancy Rapid Test Strip

Boston Easy Biotech., Inc.

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

• Primary Device ID: 00860011389224
• NIH Device Record Key: 5c745c72-4b3f-4a6a-a5d9-aacf204b432b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEB
• Version Model Number: 01PTSA0020
• Company DUNS: 119187341
• Company Name: Boston Easy Biotech., 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: 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	00860011389224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192843

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: 2024-03-08
• Device Publish Date: 2024-02-29

On-Brand Devices [BEB]

• 00860011389224: BEB hCG Pregnancy Rapid Test Strip
• 00860011389200: Digital Pregnancy Rapid Test