GUDID 05032384006359

OXOID LIMITED

Cefaclor susceptibility testing disc IVD

• Primary Device ID: 05032384006359
• NIH Device Record Key: 3ffd0b07-3d96-4529-9ee5-22bceeb91930
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CT0149B
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05032384006359 [Primary]
GS1	05032384502424 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924846

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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• 05032384029594 - TST-RPLA, Staphylococcal Toxic-Shock Syndrome Toxin Kit, 20 tests: 2024-06-19
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• 05032384003976 - MAXIMUM RECOVERY DILUENT: 2024-06-12
• 05032384000975 - NUTRIENT BROTH: 2024-06-11