Sure-Vue Rota Test

GUDID 00780311000547

Sure-Vue® Rota Test is a rapid, membrane-based immunogold assay for the qualitative detection of Rotavirus antigens in feces as an aid in the diagnosis of acute gastroenteritis caused by Rotavirus infection. This test is for professional use only.

SA SCIENTIFIC, LTD.

Rotavirus antigen IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00780311000547
• NIH Device Record Key: 3c71fa79-f255-437a-a660-a4ef9300ce36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sure-Vue Rota Test
• Version Model Number: 069005
• 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	00780311000547 [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 Rota Test]

• 00780311000547: Sure-Vue® Rota Test is a rapid, membrane-based immunogold assay for the qualitative detection o
• 00780311000530: Sure-Vue® Rota Test is a rapid, membrane-based immunogold assay for the qualitative detection o