GUDID 05056080500997

REMEL EUROPE LIMITED

Multiple meningitis-associated bacteria antigen IVD, kit, agglutination

• Primary Device ID: 05056080500997
• NIH Device Record Key: d88ca28f-f273-45e0-ab78-0c1ec6e10a04
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: R30859602
• Company DUNS: 232600853
• Company Name: REMEL EUROPE 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

Customer Support Contacts

• Phone: +4401322295600
• Email: ITechnicalSupport@remel.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056080500997 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K854852

FDA Product Code

• GTJ: Antisera, All Groups, N. Meningitidis

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: 2016-09-24

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