GUDID 05056080501222

REMEL EUROPE LIMITED

Neisseria meningitidis culture isolate antigen IVD, kit, agglutination

• Primary Device ID: 05056080501222
• NIH Device Record Key: f62ab939-a370-475e-8dae-d14182c73423
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: R30167501
• 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	05056080501222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K844762

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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• 05056080501253 - PathoDx Strep B Grouping Latex: 2021-07-29
• 05056080501260 - PathoDx Strep C Grouping Latex: 2021-07-29
• 05056080501277 - PathoDx Strep F Grouping Latex: 2021-07-29
• 05056080501284 - PathoDx Strep G Grouping Latex: 2021-07-29