SAS RSVAlert

GUDID 00780311000363

SAS™ RSVAlertAlert antigen test kit is a visual and rapid assay for the qualitative detection of Respiratory Syncytial Virus (RSV) antigen directly from nasopharyngeal specimens in neonatal and pediatric patients. The test is for in-vitro diagnostic use only. It is recommended that negative test results be confirmed by cell culture.

SA SCIENTIFIC, LTD.

Respiratory syncytial virus (RSV) antigen IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00780311000363
• NIH Device Record Key: 92223f3f-c0df-4bd1-8230-8145677d5295
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAS RSVAlert
• Version Model Number: 041130
• Company DUNS: 122092117
• Company Name: SA SCIENTIFIC, LTD.
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00780311000363 [Primary]

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: 2018-12-03
• Device Publish Date: 2018-11-02

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