#1249207
Germaine Laboratories Inc #GCRSV-502B-US

Respiratory Test Kit Rapid Check™ Respiratory Syncytial Virus (RSV) 20 Test CLIA Waived

Name: Respiratory Test Kit
Brand: Rapid Check™

TEST KIT, RSV RAPID CHECK ANTIGEN W/SWAB CLIA WAIVED (20/KT)

Respiratory Test Kit Rapid Check™ Respiratory Syncytial Virus (RSV) 20 Test CLIA Waived

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Product Specifications

McKesson #

1249207

Manufacturer #

GCRSV-502B-US

Brand

Rapid Check™

Manufacturer

Germaine Laboratories Inc

Country of Origin

Unknown

Application

Respiratory Test Kit

CLIA Classification

CLIA Waived

CLIA Classified

CLIA Waived

Contents 1

(20) Individually Packaged 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

Number of Tests

20 Test

Purchase Program Type

Standard Purchase

Reading Type

Visual Read

Sample Type

Nasopharyngeal Swab / Nasal Aspirate Sample

Specialty

Immunoassay

Test Format

Test Device Format

Test Kit Type

Rapid

Test Name

Respiratory Syncytial Virus (RSV)

Test Type

Antigen Test

Time to Results

15 Minute Results

UNSPSC Code

41116126

Features

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
Positive% Agreement: 93. 9%
Negative% Agreement: 97.7%