OVA1

GUDID 00860942000113

Ova1® is a qualitative serum test that combines the results of five immunoassays into a single numerical result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. Ova1® is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay.

VERMILLION, INC.

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• Primary Device ID: 00860942000113
• NIH Device Record Key: 450cd9c2-9e55-4202-a897-a6eade535939
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OVA1
• Version Model Number: 3.0.3.006
• Company DUNS: 861471498
• Company Name: VERMILLION, 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (844) 277.4721
• Email: kits@vermillion.com
• Phone: (844) 277.4721
• Email: kits@vermillion.com
• Phone: (844) 277.4721
• Email: kits@vermillion.com
• Phone: (844) 277.4721
• Email: kits@vermillion.com
• Phone: (844) 277.4721
• Email: kits@vermillion.com
• Phone: (844) 277.4721
• Email: kits@vermillion.com
• Phone: (844) 277.4721
• Email: kits@vermillion.com
• Phone: (844) 277.4721
• Email: kits@vermillion.com
• Phone: (844) 277.4721
• Email: kits@vermillion.com
• Phone: (844) 277.4721
• Email: kits@vermillion.com
• Phone: (844) 277.4721
• Email: kits@vermillion.com
• Phone: (844) 277.4721
• Email: kits@vermillion.com
• Phone: (844) 277.4721
• Email: kits@vermillion.com
• Phone: (844) 277.4721
• Email: kits@vermillion.com
• Phone: (844) 277.4721
• Email: kits@vermillion.com
• Phone: (844) 277.4721
• Email: kits@vermillion.com
• Phone: (844) 277.4721
• Email: kits@vermillion.com
• Phone: 844.277.4721
• Email: aspirasupport@aspirawh.com
• Phone: 844.277.4721
• Email: aspirasupport@aspirawh.com
• Phone: 844.277.4721
• Email: aspirasupport@aspirawh.com
• Phone: 844.277.4721
• Email: aspirasupport@aspirawh.com
• Phone: 844.277.4721
• Email: aspirasupport@aspirawh.com
• Phone: 844.277.4721
• Email: aspirasupport@aspirawh.com
• Phone: 844.277.4721
• Email: aspirasupport@aspirawh.com
• Phone: 844.277.4721
• Email: aspirasupport@aspirawh.com
• Phone: 844.277.4721
• Email: aspirasupport@aspirawh.com
• Phone: 844.277.4721
• Email: aspirasupport@aspirawh.com
• Phone: 844.277.4721
• Email: aspirasupport@aspirawh.com
• Phone: 844.277.4721
• Email: aspirasupport@aspirawh.com
• Phone: 844.277.4721
• Email: aspirasupport@aspirawh.com
• Phone: 844.277.4721
• Email: aspirasupport@aspirawh.com
• Phone: 844.277.4721
• Email: aspirasupport@aspirawh.com
• Phone: 844.277.4721
• Email: aspirasupport@aspirawh.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860942000113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN090004

FDA Product Code

• ONX: Ovarian Adnexal Mass Assessment Score Test System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-08
• Device Publish Date: 2018-01-15