Streptex Polyvalent Positive Control

GUDID 05056080501468

REMEL EUROPE LIMITED

Beta-haemolytic Streptococcus serological grouping IVD, control Beta-haemolytic Streptococcus serological grouping IVD, control Beta-haemolytic Streptococcus serological grouping IVD, control Beta-haemolytic Streptococcus serological grouping IVD, control Beta-haemolytic Streptococcus serological grouping IVD, control Beta-haemolytic Streptococcus serological grouping IVD, control Beta-haemolytic Streptococcus serological grouping IVD, control

• Primary Device ID: 05056080501468
• NIH Device Record Key: 315abe33-c52b-4966-bf3f-14d25e0b4a1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Streptex Polyvalent Positive Control
• Version Model Number: R30164601
• 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: +4401256694238
• Email: microbiology.techsupport.uk@thermofisher.com
• Phone: +4401256694238
• Email: microbiology.techsupport.uk@thermofisher.com
• Phone: +4401256694238
• Email: microbiology.techsupport.uk@thermofisher.com
• Phone: +4401256694238
• Email: microbiology.techsupport.uk@thermofisher.com
• Phone: +4401256694238
• Email: microbiology.techsupport.uk@thermofisher.com
• Phone: +4401256694238
• Email: microbiology.techsupport.uk@thermofisher.com
• Phone: +4401256694238
• Email: microbiology.techsupport.uk@thermofisher.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056080501468 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K842828

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: 2021-07-29
• Device Publish Date: 2021-07-21

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