#1283349
Sekisui Diagnostics #1091

Respiratory Test Kit OSOM® Respiratory Syncytial Virus Test (RSV) 25 Tests CLIA Waived

EST KIT, RSV MANUAL LATERAL FLOW RAPID (25/KT)

Respiratory Test Kit OSOM® Respiratory Syncytial Virus Test (RSV) 25 Tests CLIA Waived

Respiratory Test Kit OSOM® Respiratory Syncytial Virus Test (RSV) 25 Tests CLIA Waived

Product Specifications

McKesson #

1283349

Manufacturer #

1091

Brand

OSOM®

Manufacturer

Sekisui Diagnostics

Country of Origin

Unknown

Application

Respiratory Test Kit

Buy American Act (BAA) Compliant

No

CLIA Classification

CLIA Waived

CLIA Classified

CLIA Waived

Contents 1

(27) Test Devices in Sealed Aluminum Foil Pouch, (27) Reagents Tubes with Prefilled Extraction Buffer, (25) Anterior Nasal Swabs, Positive Control Swab, Negative Control Swab, IFU, Quick Ref

Number of Tests

25 Tests

Purchase Program Type

Standard Purchase

Reading Type

Visual Read

Sample Type

Anterior Nasal Swab Sample

Specialty

Immunoassay

Test Format

Test Swab Format

Test Kit Type

Rapid

Test Method

Lateral Flow

Test Name

Respiratory Syncytial Virus Test (RSV)

Test Type

Infectious Disease Immunoassay

Time to Results

15 Minute Results

Trade Agreement Act (TAA) Compliant

No

Features

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
For Use with Kit Provided Swabs
CLIA Complexity-WAIVED for use with anterior nasal swab