GUDID 05032384006694

OXOID LIMITED

Ofloxacin susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD

• Primary Device ID: 05032384006694
• NIH Device Record Key: 81aee416-00f7-4ab7-a5e2-223e5e3dc7a4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CT0446B
• Company DUNS: 365355452
• Company Name: OXOID LIMITED
• Device Count: 5
• 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: +441256694238
• Email: oxoid.techsupport@thermofisher
• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com
• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com
• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com
• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com
• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com
• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com
• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com
• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com
• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com
• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com
• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com
• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com
• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com
• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com
• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com
• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com
• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05032384006694 [Primary]
GS1	05032384502318 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924766

FDA Product Code

• JTN: Susceptibility Test Discs, Antimicrobial

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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• 05032384013036 - Oxoid Streptococcal Grouping Kit: 2024-06-26
• 05032384029587 - SET-RPLA, Staphylococcal Enterotoxin Kit, 20 tests: 2024-06-19
• 05032384029594 - TST-RPLA, Staphylococcal Toxic-Shock Syndrome Toxin Kit, 20 tests: 2024-06-19
• 05032384001071 - PEPTONE WATER: 2024-06-12
• 05032384003976 - MAXIMUM RECOVERY DILUENT: 2024-06-12
• 05032384000975 - NUTRIENT BROTH: 2024-06-11