GUDID 05032384096442

OXOID LIMITED

Staphylococcus aureus culture isolate antigen IVD, kit, agglutination

• Primary Device ID: 05032384096442
• NIH Device Record Key: b4e9218a-9f0a-4847-a74b-604af5d7c246
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: DR0900A
• Company DUNS: 365355452
• Company Name: OXOID 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: +441256694238
• Email: oxoid.techsupport@thermofisher

Device Identifiers

Device Issuing Agency	Device ID
GS1	05032384096442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011710

FDA Product Code

• MYI: System,Test,Genotypic Detection,Resistant Markers,Staphylococcus Colonies

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

Devices Manufactured by OXOID LIMITED

• 05032384519583 - ProSpecT Campylobacter Microplate Assay 96 Tests: 2024-06-28
• 05032384012954 - Oxoid Reaction Cards: 2024-06-26
• 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