Sekisui Diagnostics OSOM™ COVID-19 Test

Catalog No.	Detectable Analytes
22-321-107	SARS-CoV-2 Nucleocapsid Protein Antigen

Catalog No. 22-321-107 Supplier Sekisui Diagnostics Supplier No. 1092

Description

Reliable testing - Test patients of all ages within 4 days of symptom onset to avoid delaying treatment.

• A lateral flow immunochromatographic assay for the rapid, qualitative detection of SARS-CoV-2 nucleoprotein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (symptomatic) when testing is initiated within 4 days of symptom onset
• Rapid-deliver test results to your patients in only 15 minutes, at the point-of-care
• Easy to Use: A simple, CLIA-waived procedure that does not require disposable pipettes for dispensing
• Cost Efficient: Unique QC Inside™ feature that provides you with two additional test for external QC testing
• Exceptional Support: Experienced support teams and online training modules to help streamline your testing implementation
• Reagents and Materials Provided:
• 27* Test devices in sealed aluminum foil pouch with desiccant
• 27* Reagent tubes with extraction buffer (0.3 mL)
• 25 Sample collection swabs
• 1 Positive control swab
• 1 Negative control swab
• 1 Instructions for Use (IFU)
• 1 Quick Reference Guide (QRG)
• Note: Two extra test devices have been included for external QC testing

Specifications

• CE Marker: No
• Clia Complexity: Waived
• Detectable Analytes: SARS-CoV-2 Nucleocapsid Protein Antigen
• Type: COVID Test
• Disposable: Single-use
• Sterility: Non-sterile
• Form: Swab

For prescription use only.