ImmuView S. pneumoniae and L. pneumophila urinary antigen test

Basic Information

• Brand Name: ImmuView S. pneumoniae and L. pneumophila urinary antigen test
• Primary DI: 05713106105573
• Version / Model: 10557
• Catalog Number: 10557
• Company Name: Ssi Diagnostica A/S
• Labeler DUNS: 305684449
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-25
• Public Version: 1
• Public Version Date: 2022-11-02
• Public Version Status: New
• Public Device Record Key: c4854936-cd0b-446e-807f-fcbe960bda08

Device Description

Urinary antigen test

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
MJH	Legionella, Spp., Elisa	Microbiology	866.3300	2
GWC	ANTISERA, ALL TYPES, STREPTOCOCCUS PNEUMONIAE	Microbiology	866.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63143	Multiple respiratory bacteria antigen IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple types of bacteria associated with respiratory disease (e.g., S. pneumoniae and L. pneumophila) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to aid in the diagnosis of pneumonia. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05713106105573	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 37 Degrees Celsius