ImmuView S. pneumoniae and L. pneumophila urinary antigen test 10557

GUDID 05713106105573

Urinary antigen test

Ssi Diagnostica A/S

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• Primary Device ID: 05713106105573
• NIH Device Record Key: c4854936-cd0b-446e-807f-fcbe960bda08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImmuView S. pneumoniae and L. pneumophila urinary antigen test
• Version Model Number: 10557
• Catalog Number: 10557
• Company DUNS: 305684449
• Company Name: Ssi Diagnostica A/S
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713106105573 [Primary]

FDA Product Code

• MJH: Legionella, Spp., Elisa

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: 2022-11-02
• Device Publish Date: 2022-10-25

On-Brand Devices [ImmuView S. pneumoniae and L. pneumophila urinary antigen test]

• 05713106024515: Multiple respiratory bacteria antigen IVD, immunochromatographic test (ICT), rapid
• 05713106105573: Urinary antigen test