POC Rapid Check RSV Antigen Test Rapid Test, 20 tests/kit - Professional Use Only

POC Rapid Check RSV Antigen Test Rapid Test, 20 tests/kit

Rapid, qualitative detection of respiratory syncytial virus fusion protein in nasopharyngeal swabs/nasal aspirate specimens in children less than 6 years and adults over 60. Intended as an aid in the rapid laboratory diagnosis of acute respiratory syncytial virus infection in patients with such symptoms.

• 510(k) Cleared and CLIA Waived for Prescription Use
• Detection of fusion protein of respiratory syncytial virus
• Nasopharyngeal swab and nasal aspirate specimen
• Specimens collected from symptomatic patients aged less than 6 and over 60 years of age

Each kit includes everything needed to test:

• 20 Individually packaged test devices
• 20 Nasopharyngeal Swabs inside each kit.
• 1 R1 (Extraction Reagent Solution) 2 mL
• 20 Extraction Tubes
• 40 Disposable Pipettes
• 1 PC (Positive Control Reagent) 1.0 mL
• 1 NC (Negative Control Reagent) 1.0 mL
• 1 Instructions for Use
• Also Available:
• 20 Pre-Filled Saline Capsules
• 20 Extra Extraction Tubes

Specifications:

• Premier Test Performance:
• Positive % Agreement: 93. 9%
• Negative % Agreement: 97.7%
• Test Type: Rapid Tests
• Storage Temperature: 2°-30° C

*Nasopharyngeal Swab and Nasal Aspirates. Refer to the Package Insert for additional performance claims.

This product is for professional use only and cannot ship to a residence. Documentation will be required before shipment.