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Home » News » News » 5-in-1 Respiratory Antigen Rapid Test Kit | EU IVDR Certified | Bioteke

5-in-1 Respiratory Antigen Rapid Test Kit | EU IVDR Certified | Bioteke

Publish Time: 2025-06-06     Origin: Site

Bioteke 5-in-1 Respiratory Antigen Rapid Test Kit

EU IVDR Self-Test Certified | CE Marked | Multiplex Detection in 15 Minutes



Bioteke 5-in-1 Respiratory Antigen Rapid Test Kit is an excellent in vitro diagnostic device designed for fast and accurate detection of 5 common respiratory pathogens: COVID-19 (SARS-CoV-2), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Adenovirus.

This kit is a immunochromatographic assay and use the double-antibody sandwich method, delivering reliable results in just 15 minutes, making it an ideal solution for point-of-care, home self-testing, and clinical screening.

The product is EU IVDR-certified for self-testing, CE marked, and manufactured under ISO 13485 and other international quality standards.


Key Features


  • 5 results in 1 panel: COVID, Flu A, Flu B, RSV, ADV.

  • Rapid test, results in just 15 minutes.

  • Accuracy 99%.

  • Non-invasive sample collection: Anterior Nasal swabs

  • User friendly design: Simple operation & clear instructions.

  • Widely used: Ideal for home daily-testing, clinics, hospitals, pharmacies and mass screening.

  • Compliance: EU IVDR self-test certified and CE marked.


Downloads


IFU 5 IN 1 CE3018.pdf

Brochure ICA2114-7.pdf

EU-TDA certification.PDF



Why Bioteke


With 20 years of experience in in-vitro diagnostics, Bioteke is a trusted manufacturer of high-quality rapid test kits and molecular diagnostics solutions. Our commitment to product reliability, regulatory compliance, and B2B partnership flexibility makes us an ideal partner for:

1. Wholesalers/distributors/agents seeking certified respiratory testing solutions.

2. Medical service institutions seeking consumer-grade diagnostics.

3. Clinics, pharmacies, hospital chains, etc.


▉ Contact Us


Ready to bring Bioteke's 5-in-1 respiratory test kits to your market?
Let's talk! 

Submit your inquiry vis the form.

Email us at zr@bioteke.cn

☉ Phone/Whatsapp: +8613357927939




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