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InfluenzaA + InfluenzaB Rapid Test Device (FluA+B) Package Insert

InfluenzaA + InfluenzaB Rapid Test Device (FluA+B) Package Insert

Country/Region china

Company Hangzhou Laihe Biotech Co.,Ltd

Categories Rapid Test Kits

Update 2019-01-19 02:08:50

ICP License Issued by the Chinese Ministry

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InfluenzaA + InfluenzaB Rapid Test Device (FluA+B) Package Insert

1.Intended Use (1)The Flu A+B Rapid Test Device is an in vitro diagnostic test for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab, throat swab and nasal aspirate samples, using the rapid immunochromatographic method. The detection is based on...
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Description

1. Intended Use

The Flu A+B Rapid Test Device is an in vitro diagnostic test for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab, throat swab and nasal aspirate samples, using the rapid immunochromatographic method. The detection is based on the monoclonal antibodies specific for the nucleoprotein of either Influenza virus A or B. It is intended to aid in the rapid diagnosis of influenza A and B viral infection. Negative results should be confirmed by other methods, such as cell culture.

2. Limitations

(1) The Flu A+B Rapid Test Device is an acute-phase screening test for qualitative detection. Sample collected may contain antigen titles below the reagent’s sensitivity threshold, so a negative test result does not exclude infection with influenza.

(2) The Flu A+B Rapid Test Device detects both viable and non-viable influenza antigens. Test performance depends on antigen loaded in the sample and may not correlate with cell culture performed on the same sample. A positive test does not rule out the possibility that other pathogens may be present. Therefore,the results must be compared with all other available clinical and laboratory information to make an accurate diagnosis.

(3) Performance of the test has not been established for monitoring antiviral treatment of influenza.

Hangzhou Laihe Biotech Co., Ltd

Address: Room 521 Floor 5 & Floor 1,Building No. 2B,Tianhe High-Tech Park,No. 688,Bin'an Road,Changhe Sub-district,Binjiang District,Hangzhou City,Zhejiang Province,China

Contact: Helen

Tel: +86-571-86658003

Fax: +86-571-86658000

E-mailoffice@lyher.com

Zip:310052

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China InfluenzaA + InfluenzaB Rapid Test Device (FluA+B) Package Insert

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