Sure-Vue RSV Test

Basic Information

• Brand Name: Sure-Vue RSV Test
• Primary DI: 00780311000561
• Version / Model: 041130
• Company Name: SA SCIENTIFIC, LTD.
• Labeler DUNS: 122092117
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-02
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 4d4a2f24-7474-4547-8465-a1ce8419c650

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
49500	Respiratory syncytial virus (RSV) 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 respiratory syncytial virus (RSV) 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. 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	00780311000561	GS1