Overa

GUDID 00860942000106

The Overa® test is a qualitative serum test that combines the results of five immunoassays into a single numeric 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. The Overa® test is intended to aid in assessing whether a woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy as part of the preoperative evaluation. The Overa® test must be interpreted in conjunction with an independent clinical and imaging evaluation. The test is not intended as a screening or stand-alone diagnostic assay.

Aspira Women's Health Inc.

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• Primary Device ID: 00860942000106
• NIH Device Record Key: a0635653-7c2e-4c5b-8621-73d46e89204c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Overa
• Version Model Number: 4.0.0
• Company DUNS: 861471498
• Company Name: Aspira Women's Health 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@aspirawh.com
• Phone: 844-277-4721
• Email: kits@aspirawh.com
• Phone: 844-277-4721
• Email: kits@aspirawh.com
• Phone: 844-277-4721
• Email: kits@aspirawh.com
• Phone: 844-277-4721
• Email: kits@aspirawh.com
• Phone: 844-277-4721
• Email: kits@aspirawh.com
• Phone: 844-277-4721
• Email: kits@aspirawh.com
• Phone: 844-277-4721
• Email: kits@aspirawh.com
• Phone: 844-277-4721
• Email: kits@aspirawh.com
• Phone: 844-277-4721
• Email: kits@aspirawh.com
• Phone: 844-277-4721
• Email: kits@aspirawh.com
• Phone: 844-277-4721
• Email: kits@aspirawh.com
• Phone: 844-277-4721
• Email: kits@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
• Phone: 844.277.4721
• Email: aspirasupport@aspirawh.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860942000106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150588

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-01
• Device Publish Date: 2022-11-23