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Devices Detecting Influenza A, B, And C Virus Antigens

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Company Name
Description
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Status™ COVID-19/Flu
PRINCETON BIOMEDITECH CORPORATION
Status™ COVID-19/Flu A&B Antigen test kit, 25 tests
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Fluoro-CheckTM Influenza A+B
NANO-DITECH CORPORATION
An in vitro diagnostic test for the detection of influenza A and influenza B viral nucleoprotein antigens from nasopharyngeal secretion specimens in symptomatic patients.
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Remel
REMEL, INC.
Xpect Flu A&B KT/20TST
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ImmunoCard STAT! FLU A&B
MERIDIAN BIOSCIENCE, INC.
ImmunoCard STAT! Flu A&B is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly form nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.Moderate Complexity when used with Nasal Wash/Aspirate Samples. CLIA Waived when used with Nasal and Nasopharyngeal Swabs.
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ImmunoCard STAT! FLU A&B Nasopharyngeal Wash/Aspriate Kit
MERIDIAN BIOSCIENCE, INC.
Nasopharyngeal Wash/Aspirate Kit for use with ImmunoCard STAT! FLU A&B. ImmunoCard STAT! Flu A&B is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly form nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.Moderate Complexity when used with Nasal Wash/Aspirate Samples.
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OSOM ULTRA PLUS FLU A&B Control Kit
SEKISUI DIAGNOSTICS, LLC
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OSOM ULTRA PLUS FLU A&B Test
SEKISUI DIAGNOSTICS, LLC
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Acucy Influenza A&B Control Kit
SEKISUI DIAGNOSTICS, LLC
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Acucy Flu Test Kit
SEKISUI DIAGNOSTICS, LLC
Acucy Influenza A&B Test Kit
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Acucy Calibration Device
SEKISUI DIAGNOSTICS, LLC
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Acucy System
SEKISUI DIAGNOSTICS, LLC
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OSOM Ultra Flu Aspirate 25T Kit
SEKISUI DIAGNOSTICS, LLC
OSOM Ultra Flu Aspirate 25T Kit
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OSOM Ultra Flu A&B 25T Kit
SEKISUI DIAGNOSTICS, LLC
OSOM Ultra Flu A&B 25T Kit
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BinaxNOW Influenza A & B Card 2 Control Swab Kit
Alere Scarborough, Inc.
Control Swabs ntended for use only with BinaxNOW™ Influenza A & B 2 Card product.
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BinaxNOW Influenza A & B Card 2
Alere Scarborough, Inc.
A rapid test for the qualitative detection of Influenza A & B antigens with NP swab and nasal swab specimens.
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Alere Influenza A & B Control Swab Kit
Alere Scarborough, Inc.
The Control Swabs are intended for use only with the Alere Influenza A & B Test.
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Alere Influenza A & B Test
Alere Scarborough, Inc.
A rapid test for the qualitative detection of Influenza A & B Antigens in nasal swab specimens.
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ID NOW Influenza A & B Control Swab Kit
Alere Scarborough, Inc.
Control Swabs intended for use only with the ID NOW Influenza A & B product.
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ID NOW Influenza A & B 2
Alere Scarborough, Inc.
A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimens.
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Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
Alere Scarborough, Inc.
Control Swabs intended for use only with Alere BinaxNOW® Influenza A & B Card 2 product.
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Alere BinaxNOW Influenza A & B Card 2
Alere Scarborough, Inc.
A rapid test for the qualitative detection of Influenza A & B antigens with NP swab and nasal swab specimens
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Nano-Check Influenza+COVID-19 Dual Test
NANO-DITECH CORPORATION
The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. The Nano-Check™ Influenza+COVID-19 Dual Test is only for in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been cleared or approved.
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ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen Test
Lumos Diagnostics, Inc.
ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen Test Kit, 25 tests
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BD Veritor™ System CLIA-Waived Combo Pack
BECTON, DICKINSON AND COMPANY
BD Veritor™ System CLIA-Waived Combo Pack Contains: 2xBD Veritor ™ System for Rapid Detection of Flu A+B, CLIA-Wavied Kits (Cat. No. 256045) 1xBD Veritor ™ System Reader (Cat. No. 256055)
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BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waved kit
BECTON, DICKINSON AND COMPANY
Kit Flu A+B 30 Test Physician Veritor
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BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kit
BECTON, DICKINSON AND COMPANY
Kit Flu A+B 30 Test Hospital Veritor