CE3018, Bioteke 5-in-1 Has Obtained EU IVDR Self-test Certification!

Important certification 

Bioteke 5-in-1 test kit (Commercial Name“Multiple Respiratory Multipathogen Antigen Test Kit”) has obtained the EU IVDR (In Vitro Diagnostic Medical Device Regulation) CE‑3018 self-test certification on May 30, 2025, and is officially allowed to be sold directly in the EU/EEA as a home self-test.

The CE3018 mark indicates that the product meets the strict safety and performance requirements for in vitro self-testing devices designed for ordinary consumers under the latest IVDR (EU Regulation 2017/746).

Product functions and features

• Detect 5 respiratory viruses simultaneously

SARS-CoV-2(COVID-19)

Influenza A virus

Influenza B virus

Respiratory syncytial virus(RSV)

Respiratory adenovirus(ADV)

• Rapid test

Time to results within 15 minutes, no equipments required.

• High accuracy

Total accuracy 99%.

• Specimen

Non-invasive anterior nasal swab, easy to use, for home users.

• Compliance

Produced in accordance with ISO13485 quality management system, CE mark; multi-language instructions available (English, French, German, Spanish, Italian, Polish, etc.)

• Specification

Provide 1/2/5/20/50 tests/kit multiple specifications packaging, valid for 2 years, storage at 2~30℃.

Usage scenarios

Daily home monitoring: Users can test at home and quickly screen for early respiratory symptoms.

Public health use: Applicable to routine monitoring in crowded places such as schools and nursing homes.

Medical auxiliary tool: Can be used as an on-site screening method in hospitals or clinics to supplement the primary judgment before PCR testing.

Travel or activity epidemic prevention: Applicable to rapid screening before entry and exit, etc.

How to purchase?

This product is only available for bulk purchase through Business to Business method.

For product further details and agent policy, please contact the Bioteke team.

Tel: 86-510-8332-3992

Phone: 86-133-5792-7939

E-mail: zr@bioteke.cn

Add: No.90 Huiming Road, Huishan, Wuxi 214174, China