IMAGEN RESPIRATORY SCREEN POS CON SLIDE

Basic Information

• Brand Name: IMAGEN RESPIRATORY SCREEN POS CON SLIDE
• Primary DI: 05032384503070
• Version / Model: S612130-2
• Company Name: OXOID LIMITED
• Labeler DUNS: 365355452
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-03
• Public Version: 1
• Public Version Date: 2024-07-11
• Public Version Status: New
• Public Device Record Key: f6c1f3ce-2f1b-476d-b0a8-c0bb4887d7b9

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GNW	Antisera, Cf, Influenza Virus A, B, C	Microbiology	866.3330	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48247	Multiple-genus respiratory virus antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from multiple virus genera associated with respiratory diseases in a clinical specimen. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05032384503070	GS1

Premarket Submissions

Submission Number	Supplement Number
K973954	000