X FACTOR

GUDID 05032384034055

OXOID LIMITED

X factor differentiation disc IVD

• Primary Device ID: 05032384034055
• NIH Device Record Key: 42c5ff6d-a48b-429a-aa5c-84a37745ca6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X FACTOR
• Version Model Number: DD0003T
• Company DUNS: 365355452
• Company Name: OXOID LIMITED
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05032384034055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K802500

FDA Product Code

• JTO: Discs, Strips And Reagents, Microorganism Differentiation

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: 2022-12-12
• Device Publish Date: 2022-12-04

On-Brand Devices [X FACTOR]

• 05032384104635: DD0003B
• 05032384034055: DD0003T