Product Overview
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.
Product Features
- 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
Product Specifications
| Catalog Number/SKU | MF- GCRSV-502B-US |
| Application | Respiratory Test Kit |
| CLIA Classification | CLIA Waived |
| Test Format | Test Device Format |
| Test Type | Antigen Test |
| Sample Type | Nasopharyngeal Swab / Nasal Aspirate |
| Reading Type | Visual Read |
| Test Time | 15 Minutes |
| Positive Percent Agreement | 93.9% |
| Negative Percent Agreement | 97.7% |
| Intended Use | In vitro diagnostic use for children under 6 years and adults over 60 years |
| Kit Contents | 20 test devices, 20 nasopharyngeal swabs, 2 mL extraction reagent solution, 20 extraction tubes, 40 disposable pipettes, 1 mL positive control reagent, 1 mL negative control reagent, instructions for use |
| Storage Conditions | Store at 2°C – 30°C (36°F – 86°F) |
| Shelf Life | 24 months from date of manufacture |
| CPT Code | 87807Q |
| Regulatory Status | FDA 510(k) Cleared (K021789), CLIA Waived (CR230303) |
| Sample Transport Compatibility | Compatible with various viral transport media |
| Use Case | Point-of-care testing in emergency departments, urgent care centers, and outpatient clinics |
