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#100533820 | Mfg #430100 | Clinical Laboratory

Rapid Test Kit BinaxNOW® Infectious Disease Immunoassay Respiratory Syncytial Virus Test (RSV) Nasopharyngeal Swab / Nasal Wash Sample 10 Tests CLIA Waived

TEST KIT, WAIVED BINAX NOW RSV (10/BX)
Rapid Test Kit BinaxNOW® Infectious Disease Immunoassay Respiratory Syncytial Virus Test (RSV) Nasopharyngeal Swab / Nasal Wash Sample 10 Tests CLIA Waived

BinaxNOW® RSV Card is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) fusion protein antigen in nasal wash and nasopharyngeal swab specimens from symptomatic patients

Product Specifications

MSFH #
100533820
Manufacturer #
430100
Brand
(10) Test Cards, CLIA Waived, Rapid Test Kit, United States, Abbott Rapid Dx North America LLC, BinaxNOW®, Transfer Pipettes
Manufacturer
Positive Control Swab (Inactivated RSV)
Country of Origin
Negative Control Swab
Application
Elution Solution and NP Patient Swabs (with CLIA Waived Kits)
CLIA Classification
Product Insert
Contents 1
Procedural Card
Number of Tests
10 Tests
Product Dating
MSFH Acceptable Dating: we will ship >= 90 days
Reading Type
Visual Read
Sample Type
Nasopharyngeal Swab / Nasal Wash Sample
Test Format
Test Card Format
Test Method
Lateral Flow Method
Test Name
Respiratory Syncytial Virus Test (RSV)
Test Type
Infectious Disease Immunoassay
Time to Results
15 Minute Results
UNSPSC Code
41116144

Description

Shelf Life: 24 months from the date of manufacture

Retrospective nasal wash Sensitivity: 89% Specificity: 100%

Prospective NP swab Sensitivity: 93% Specificity 93%

This test is intended for in vitro diagnostic use to aid in the diagnosis of respiratory syncytial virus infections in neonatal and pediatric patients under the age of 5

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