GUDID 05056080501062

REMEL EUROPE LIMITED

Salmonella paratyphi total antibody IVD, kit, agglutination

• Primary Device ID: 05056080501062
• NIH Device Record Key: e224c4c1-d19e-40d6-acee-41b191c5388d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: R30165401
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056080501062 [Primary]

FDA Product Code

• GSN: Antiserum, Positive And Negative Febrile Antigen Control Serum

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

Devices Manufactured by REMEL EUROPE LIMITED

• 05056080500775 - Salmonella H z Agglutinating Sera: 2021-07-29
• 05056080501031 - Vibrio cholerae Inaba Agglutinating Sera: 2021-07-29
• 05056080501239 - PathoDx Strep Grouping Kit: 2021-07-29
• 05056080501246 - PathoDx Strep A Grouping Latex: 2021-07-29
• 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