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Multiple Respiratory Multipathogen Antigen Test Kit (4 Results)

1.These antigen tests can selectively detect four items, namely: SARS-CoV-2, Influenza A(FluA), Influenza B(Flu B), RSV.
2.These antigen tests are included under “Category A” of the EU common list.
  • BioTeke

Warm warning: This product is not available for US market.

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%

A. Product Name

Multiple Respiratory Multipathogen Antigen Test Kit (immunochromatagraphic assay)

B. 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 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.

C. Advantages

  1. Superior performance and high accuracy.

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

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

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

  5. Lower cost.

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

D. Product qualifications(By Dec.2nd,2022)

Multiple Respiratory multipathogen antigen test kit 

(immunochromatographic assay)

EU HSC Common List 欧盟抗原检测卡通用清单
Malaysia Registration 马来西亚注册
CE Certification – CIBG Registration LetterCE 证书-CIBG 注册信
CE Certification –CIBG Registration ProveCE 证书-CIBG 网站注册证明
CE Certification–EC Declaration of ConformityCE 证书-EC 符合性声明
Export Qualified Suppliers商务部出口白名单
Free sale certificate-Malaysia自由销售证明-马来西亚
Free sale certificate-Mexico自由销售证明-墨西哥
Free sale certificate-Indonesia自由销售证明-印尼
Free sale certificate-Sri Lanka自由销售证明-斯里兰卡
Free sale certificate-United Arab Emirates自由销售证明-阿联酋
ISO 13485 CertificateISO 13485 证书
ISO 9001 CertificateISO 9001 证书
ISO 45001 CertificateISO 45001职业健康安全管理体系认证证书
ISO 14001 CertificateISO 14001环境管理体系认证证书
IPMS Certificate知识产权管理体系认证证书

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