Evidence Pregnancy Test

GUDID 00868926000326

VEDALAB

Estriol-16-alpha-glucuronide IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 00868926000326
• NIH Device Record Key: 599a22b6-ad12-49f2-915a-f552efa9b757
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evidence Pregnancy Test
• Version Model Number: 3066
• Company DUNS: 770675080
• Company Name: VEDALAB
• 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	00868926000326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962721

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-24

Devices Manufactured by VEDALAB

• 00868926000326 - Evidence Pregnancy Test: 2018-07-06
• 00868926000326 - Evidence Pregnancy Test: 2018-07-06
• 00868926000302 - Syphilis Health Check: 2018-03-29