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Multiple Respiratory Multipathogen Antigen Test Kit (3 Results & 4 Results & 5 Results)

(These antigen tests are included under “Category A” of the EU common list.)
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A. Intended Use:

     This kit is only used for the in vitro qualitative detection of Multiple Respiratory Multipathogen Antigen from human nasopharyngeal swabs specimens. Multiple Respiratory Multipathogen Antigen Test Kit is an immunochromatographic double-antibody sandwich assay intended for the qualitative detection and differentiation of SARS-CoV-2/Influenza A virus/Influenza B virus /Respiratory syncytial virus and Adenovirus antigen from individuals who are suspected of respiratory tract disease infection.

    This kit is suitable for the auxiliary diagnosis of respiratory diseases, the results are for clinical reference only and cannot be used as the sole basis for diagnosis and exclusion decision. The clinical diagnosis and treatment of patients should be considered in combination with their symptoms/signs, medical history, other laboratory tests and treatment responses. Positive test result needs to be further confirmed, negative result does not preclude respiratory diseases viruses infection.

    This kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures.



B. Three  Options:

a. Multiple Respiratory Multipathogen Antigen Test Kit (3 Results of Diseases)

(This kit can be detected three items: SARS-CoV-2、Influenza A virus and Influenza B).

3联



b. Multiple Respiratory Multipathogen Antigen Test Kit (4 Results of Diseases)

This kit can be detected four items: SARS-CoV-2、Influenza A virus 、Influenza B virus and Respiratory syncytial virus. 

(a)These antigen tests are included under “Category A” of the EU common list:

Prospective clinical field study
Study in Poland.Sample size : 103 positive ,325 negative .Sensitivity:90.29% ; specificity:99.04%


4联



c.Multiple Respiratory Multipathogen Antigen Test Kit (5 Results of Diseases)

This kit can be detected four items: SARS-CoV-2、Influenza A virus 、Influenza B virus 、Respiratory syncytial virus and Adenovirus antigen.

5联




C. Advantages

  a. Superior performance and high accuracy.

  b. The multi-color system is more conducive to the interpretation of inspector and can help reduce the chance of misjudgment.

  c. Two-way chromatography, one sampling, multiple detections.Operators' detection steps will be simpler.

  d. Automation degree is high, and the production efficiency is several times higher than that of other enterprises.

  e. Lower cost.

  f. The product form is flexible.Multiple inspections can be combined according to customers' requirements.

主图2(详情页)


D. Product qualifications(By Sept.22,2023)

Multiple Respiratory multipathogen antigen test kit 


Malaysia Registration
CE Certification – CIBG Registration Letter
CE Certification –CIBG Registration Prove
CE Certification–EC Declaration of Conformity
Export Qualified Suppliers
Free sale certificate-Malaysia
Free sale certificate-Mexico
Free sale certificate-Indonesia
Free sale certificate-Sri Lanka
Free sale certificate-United Arab Emirates
ISO 13485 Certificate
ISO 9001 Certificate
ISO 45001 Certificate
ISO 14001 Certificate
IPMS Certificate


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