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#1001216939 | Mfg #FAB1100CW | Clinical Laboratory

Rapid Test Kit Accula™ Molecular Diagnostic Influenza A + B Nasal Swab Sample 25 Tests CLIA Waived for Nasal Swabs

TEST KIT, ACCULA FLU A-B (25/KT)
Rapid Test Kit Accula™ Molecular Diagnostic Influenza A + B Nasal Swab Sample 25 Tests CLIA Waived for Nasal Swabs

Intended use The Accula™ Flu A/Flu B Test performed on the Accula™ Dock or Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA

Product Specifications

MSFH #
1001216939
Manufacturer #
FAB1100CW
Brand
Accula™, Mesa BioTech Inc
Manufacturer
Unknown
Country of Origin
Rapid Test Kit
Application
(25) Transfer Pipettes, (25) Vials Nasal Swab Buffer, (25) Sterile Swabs for Nasal Collection, CLIA Waived for Nasal Swabs, (25) Test Cassettes
CLIA Classification
Flu A Positive / B Negative Control Swab
Contents 1
Flu B Positive / A Negative Control Swab
For Use With
For use with Accula Dock / Silaris Dock
Number of Tests
25 Tests
Product Dating
MSFH Acceptable Dating: we will ship >= 90 days
Reading Type
Machine Read
Sample Type
Nasal Swab Sample
Test Format
Cassette Format
Test Method
NAAT
Test Name
Influenza A + B
Test Type
Molecular Diagnostic
Time to Results
30 Minute Results
UNSPSC Code
41116144

Description

The Accula™ Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection

The Accula™ Flu A/Flu B Test is a point of care Nucleic Acid Amplification Test (NAAT) for detection of influenza A virus and/or influenza B virus in patients with flu-like symptoms in approximately 30 minutes

A Certificate of Waiver is required to perform this test in a CLIA Waived environment

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