IMAGEN RESPIRATORY SCREEN POS CON SLIDE

GUDID 05032384503070

OXOID LIMITED

Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control Multiple-genus respiratory virus antigen IVD, control

• Primary Device ID: 05032384503070
• NIH Device Record Key: f6c1f3ce-2f1b-476d-b0a8-c0bb4887d7b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMAGEN RESPIRATORY SCREEN POS CON SLIDE
• Version Model Number: S612130-2
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05032384503070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973954

FDA Product Code

• GNW: Antisera, Cf, Influenza Virus A, B, C

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: 2024-07-11
• Device Publish Date: 2024-07-03

Devices Manufactured by OXOID LIMITED

• 05032384188796 - Oxoid™ Bacitracin Diagnostic Discs: 2024-07-16
• 05032384574964 - Ceftazidime (10 ug) CAZ10 Antimicrobial Susceptibility Test Discs: 2024-07-15
• 05032384519828 - ProSpecT™ Wash Buffer: 2024-07-15
• 05032384503032 - IMAGEN CHLAMYDIA POSITIVE CONTROL SLIDE: 2024-07-11
• 05032384503070 - IMAGEN RESPIRATORY SCREEN POS CON SLIDE: 2024-07-11
• 05032384503070 - IMAGEN RESPIRATORY SCREEN POS CON SLIDE: 2024-07-11
• 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