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Sekisui Diagnostics OSOM RSV Test
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Anterior Nasal Swab
Description
- The OSOM™ RSV Test is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigen in anterior nasal swab specimens from patients with signs and symptoms of respiratory infections
- This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and pediatric patients aged 6 months to 6 years old, and adults over 60 years of age
- Test results are interpreted at 15 minutes visually
- REAGENTS AND MATERIALS Provided
- 27* - Test devices in sealed aluminum foil pouch with desiccant
- 27* - Reagent tubes prefilled with extraction buffer (350 μL) and dropper tips
- 25 - Sample collection swabs (Anterior Nasal)
- 1 - Positive control swab (noninfectious RSV antigen)
- 1 - Negative control swab (noninfectious nasal clinical matrix)
- 1 - Instructions for Use (IFU)
- 1 - Quick Reference Guide (QRG)
- NOTE: Two extra test devices have been included for external QC testing.

Specifications
Specifications
CE Marker | No |
Clia Complexity | Waived |
DoA Calibrators | No |
Type | Anterior Nasal Swab |
For Use With (Application) | RSV |
Form | Swab |
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