GUDID 05056080500041

REMEL EUROPE LIMITED

Fibrinogen degradation product (FDP) IVD, kit, agglutination, rapid Fibrinogen degradation product (FDP) IVD, kit, rapid agglutination, clinical Fibrinogen degradation product (FDP) IVD, kit, rapid agglutination, clinical Fibrinogen degradation product (FDP) IVD, kit, rapid agglutination, clinical Fibrinogen degradation product (FDP) IVD, kit, rapid agglutination, clinical Fibrinogen degradation product (FDP) IVD, kit, rapid agglutination, clinical Fibrinogen degradation product (FDP) IVD, kit, rapid agglutination, clinical Fibrinogen degradation product (FDP) IVD, kit, rapid agglutination, clinical Fibrinogen degradation product (FDP) IVD, kit, rapid agglutination, clinical Fibrinogen degradation product (FDP) IVD, kit, rapid agglutination, clinical Fibrinogen degradation product (FDP) IVD, kit, rapid agglutination, clinical Fibrinogen degradation product (FDP) IVD, kit, rapid agglutination, clinical

• Primary Device ID: 05056080500041
• NIH Device Record Key: 18df1491-a35f-4ea3-a97f-0cdc71ad04a3
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: R30852301
• Company DUNS: 232600853
• Company Name: REMEL EUROPE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• Phone: +4401322295600
• Email: ITechnicalSupport@remel.com
• Phone: +4401322295600
• Email: ITechnicalSupport@remel.com
• Phone: +4401322295600
• Email: ITechnicalSupport@remel.com
• Phone: +4401322295600
• Email: ITechnicalSupport@remel.com
• Phone: +4401322295600
• Email: ITechnicalSupport@remel.com
• Phone: +4401322295600
• Email: ITechnicalSupport@remel.com
• Phone: +4401322295600
• Email: ITechnicalSupport@remel.com
• Phone: +4401322295600
• Email: ITechnicalSupport@remel.com
• Phone: +4401322295600
• Email: ITechnicalSupport@remel.com
• Phone: +4401322295600
• Email: ITechnicalSupport@remel.com
• Phone: +4401322295600
• Email: ITechnicalSupport@remel.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056080500041 [Primary]

FDA Product Code

• DAP: Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

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• 05056080501277 - PathoDx Strep F Grouping Latex: 2021-07-29
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