Sure-Vue RSV Test

GUDID 00780311000561

Sure-Vue® RSV 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.

SA SCIENTIFIC, LTD.

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

• Primary Device ID: 00780311000561
• NIH Device Record Key: 4d4a2f24-7474-4547-8465-a1ce8419c650
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sure-Vue RSV Test
• 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	00780311000561 [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

On-Brand Devices [Sure-Vue RSV Test]

• 00780311000578: Sure-Vue® RSV antigen test kit is a visual and rapid assay for the qualitative detection of Res
• 00780311000561: Sure-Vue® RSV antigen test kit is a visual and rapid assay for the qualitative detection of Res