ROMA

GUDID 00869164000024

ROMA (HE4 EIA + ARCHITECT CA125II) Software disk

Fujirebio Diagnostics, Inc.

Laboratory instrument/analyser application software IVD

• Primary Device ID: 00869164000024
• NIH Device Record Key: 3fc2e098-063a-4821-8ce9-07d7c013dedb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROMA
• Version Model Number: 404-10US
• Company DUNS: 048524263
• Company Name: Fujirebio Diagnostics, 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: true
• 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: 9999999999
• Email: xx@xx.xxx
• Phone: 9999999999
• Email: xx@xx.xxx
• Phone: 9999999999
• Email: xx@xx.xxx
• Phone: 9999999999
• Email: xx@xx.xxx
• Phone: 9999999999
• Email: xx@xx.xxx
• Phone: 9999999999
• Email: xx@xx.xxx
• Phone: 9999999999
• Email: xx@xx.xxx
• Phone: 9999999999
• Email: xx@xx.xxx
• Phone: 9999999999
• Email: xx@xx.xxx
• Phone: 9999999999
• Email: xx@xx.xxx
• Phone: 9999999999
• Email: xx@xx.xxx
• Phone: 9999999999
• Email: xx@xx.xxx
• Phone: 9999999999
• Email: xx@xx.xxx
• Phone: 9999999999
• Email: xx@xx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869164000024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160090

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

Devices Manufactured by Fujirebio Diagnostics, Inc.

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• 00869164000062 - Serodia TP-PA Kits: 2023-12-14 220 test kits
• 00869164000079 - Emit Cyclosporine Sample: 2023-12-14
• 00869164000048 - Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator Tool: 2022-03-22 Software
• 00869164000000 - MESOMARK: 2018-07-06
• 00869164000017 - Lumipulse G ROMA: 2018-07-06 Software Disk
• 00869164000024 - ROMA: 2018-07-06ROMA (HE4 EIA + ARCHITECT CA125II) Software disk
• 00869164000024 - ROMA: 2018-07-06 ROMA (HE4 EIA + ARCHITECT CA125II) Software disk