Certification: ISO9001, ISO13485, ISO11737, CE

antigen test
monkeypox
pcr
SARS-CoV-2 antigen test

Bioteke Corporation Which Focus On Molecular Diagnostics 

Bioteke Corporation, which focus on molecular diagnostics and rapid detection, particularly, on nucleic acid extraction, is a professional high-tech manufacturer. It is set in Wuxi City, Jiangsu province, China. By 2020, Bioteke has  dozens of patents and more than 20 software copyrights. As a "National High-tech Enterprise" , Bioteke holds the philosophy to offer products with low price, high quality and superior services to the world, and insists on pursuing higher excellence.

 

More About Bioteke

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The company was founded in 2010
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More than 47 invention patents
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The factory covers an area of more than 50000 square meters
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It has more than 500 employees and technicians

Patent technology

By 2020, Bioteke has  dozens of patents and  more than 20 software copyrights. It has passed ISO13485 Quality Management System Certification. 

Independent innovation

Our company adheres to independent innovation and is a Chinese brand company. It has become a well-known independent R & D biotechnology company in China.

Enterprise scale

The company has over 300 employees and covers a factory area of more than 6000 square meters.

SARS-CoV-2 Detection Solution

Within 33 minutes, the new technology shortens the detection time of covid-19 nucleic acid

SAMPLING

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Sample collection is the first step of nucleic acid detection. There are obvious differences in performance among sampling kits from different manufactures. The differences are mainly reflected ...

 

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EXTRACTION

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Bioteke Corporation, which focus on molecular diagnostics and rapid detection, particularly, on nucleic acid extraction, is a professional high-tech manufacturer. It is set in Wuxi City, Jiangsu province, China.

 

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DETECTION

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  • 10uL reaction system saves reagents and samples.
  • 4-color fluorescence channels.
  • 20~30min to complete 40 cycles.
  • 8~12℃/s temperature change speed.

 

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Bioteke's Product Qualification Certificate Summaries(by Mar.17th,2022)
NO. Product Name Product Qualification Certificates (continually updated)
1 Disposable Virus Sampling Swab Kits CE Certification –CIBG Registration Letter/ CE Certification–EC Declaration of Conformity/ MHRA Registration/ MHRA Registration- UKCA Declaration of Conformity/ CFDA(NMPA) Registration/ Canada MDEL Registration/ Malaysia Registration/ Indonesia Registration/ Italy Registration/ Australian Register of Therapeutic Goods Certificate/ Brazil ANVISA Registration-ST7001/ Botswana registration exemption/ ISO 11737 Test Report/ REACH Test Report/ EN11137 Test Report/ ISO 13485 Certificate/ ISO 9001 Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate
2 Disposable Sterile Sampling Swab CE Certification–EC Declaration of Conformity/ BSI EU Quality Management System Certificate/ Test Report/ ISO 13485 Certificate/ ISO 9001 Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate
3 Nucleic Acid Extraction Kit CE Certification –CIBG Registration Letter/ CE Certification –EC Declaration of Conformity/ MHRA Registration/ MHRA Registration-UKCA Declaration of Conformity/ CFDA(NMPA) Registration/ NQA Compliance Report/ NMPA Registration/ Canada MDEL Registration/ Italy Registration/ Australian Register of Therapeutic Goods Certificate/ Brazil ANVISA Registration-DP46XX/ Brazil ANVISA Registration-AU17011/ EN11737 test report-Prepackaged consumables/ ISO 13485 Certificate/ ISO 9001 Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate
4 Automated Nucleic Acid Extraction System CE Certification –CIBG Registration Letter/ CE Certification –EC Declaration of Conformity/ MHRA Registration/ MHRA Registration-UKCA Declaration of Conformity/ NQA Compliance Report/ CFDA(NMPA) Registration/ Canada MDEL Registration/ Malaysia Registration/ Indonesia Registration/ Peru Registration exempt/ Italy Registration/ Australian Register of Therapeutic Goods Certificate/ Brazil ANVISA Regsitration/ Saudi Arabia Registration/ Government recommends/ Certificate for Exportation of Medical Products/ Product Test Report-AU1001/ Product Test Report-AU1001-96/ Product Test Report-AU1001S/ ISO 13485 Certificate/ISO 9001 Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate
5 Fast real-time fluorescence PCR analyzer(BTK-8 CE Certification-IVD Notification Certificate/ CE Certification-E.A.R. Certificate/ CE Certification-Notify body: 2853/ Belgium Registration/ Australian Register of Therapeutic Goods Certificate/ Peru Registration exempt/ Italy Registration/ Instrument Test Report/ ISO 13485 Certificate/ ISO 9001 Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate
6 SARS-CoV-2 Antigen Test Kit
(colloidal gold method)

For self-test
CE Certification: CE1434/ Export Qualified Suppliers (German BfarM special approval for self-test)/ Bfarm Special approval/ EU HSC common list/ Thailand Registration (self-test for saliva)/ Thailand Registration (self-test for nasal swab)/ /  Thailand Clinical evaluation-1/ Thailand Clinical evaluation-2/ ISO 13485 Certificate-MDSAP/ ISO 9001 Certificate/ ISO 9001Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate
7 SARS-CoV-2 Antigen Test Kit
(colloidal gold method)
For professional use
CE Certification –CIBG Registration Letter/ CE Certification –CIBG Registration Prove/ CE Certification –EC Declaration of Conformity/ MHRA Registration/ MHRA Registration- UKCA Declaration of Conformity/ EU COVID-19 In Vitro Diagnostic Devices and Test Methods Database/ Export Qualified Suppliers/ Export Qualified Suppliers (German BfarM special approval for self-test)/ Bfarm Special approval/ Bfarm List of Antigen-tests of the coronavirus SARS-CoV-2/ PEI tests/ Czech List of antigenic tests for which issued by the ministry exemption/ Austria Registration/ Italy Registration/ Nepal List of approved COVID-19 Antigen Kits/ EU HSC common list/ EU HSC common list/ FIND list of immunoassays and molecular tests for COVID-19/ Malaysia List of Recommended for Use of Covid-19 IVD Test kit (Professional use only)/ Swiss Lists of rapid tests for SARS-CoV-2 for professional use/ Bulgaria list of rapid antigen test/ France COVID-19 Diagnostic test list - For
nasopharyngeal swab/ Thailand List of Test Kits for COVID-19 -Antigen Rapid Test (Professional Use Only)/ Thailand List of Test Kits for COVID-19 -Antigen Rapid Test (Professional Use Only)/ Bangladesh Emergency Use Authorization (EUA)/ Indonesia Registration/ Belgium famhp List of the recommended tests/ Ghana Registration/ Saudi Arabia Registration/ Thailand Clinical evaluation-1/ Thailand Clinical evaluation-2/ ISO 13485 Certificate-MDSAP/ ISO 13485 Certificate/ ISO 9001 Certificate/ Free Sale Certificate-Ghana/ ISO 13485 Certificate-MDSAP/ ISO 9001Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate
8 Freeze-dried Novel Coronavirus (SARS-CoV-2)
Nucleic Acid Detection Kit
(Fluorescence PCR)
CE Certification –CIBG Registration Letter/ CE Certification –EC Declaration of Conformity/ CE Certification –CIBG Website notify/ MHRA Registration/ MHRA Registration-UKCA Declaration of Conformity/ EU Website notify/ Export Qualified Suppliers/ Italy Registration/ Philippines special certification of COVID-19 Diagnostic Kits – PR2019-D/ ISO 13485 Certificate-MDSAP/ ISO 9001 Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate
9 Novel Coronavirus (SARS-CoV-2)
Nucleic Acid Detection Kit
(Fluorescence PCR)
CE Certification –CIBG Registration Letter/ CE Certification –EC Declaration of Conformity/ EU COVID-19 In Vitro Diagnostic Devices and Test Methods Database/ Export Qualified Suppliers/ Italy Registration/ Bangladesh Emergency Use Authorization
(EUA)/ ISO 13485 Certificate-MDSAP/ ISO 9001 Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate
10 Hydrogen Peroxide Sterilizer CE Certification/ EPA Certification/ Test Report-DS1001/ Test Report-DS1000, DS1001, DS1002/ Test Report-DS1001/ Test Report-DS1001 (8% Hydrogen Peroxide)/ Sterilizer Test Report-DS1001 (35% Hydrogen Peroxide)/ Electrical Safety Report/ Health Inspection Institute Registration/ Hygiene License/ ISO 13485 Certificate/ ISO 9001 Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate
11 Nucleic acid aerosol pollution removal instrument CE Certification/ Test Report-NC1001/ Test Report/ New product and new technology appraisal and acceptance certificate/Electrical safety report/ Disinfection Products Record/ Hygiene License/ ISO 13485 Certificate-MDSAP/ ISO 9001 Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate

Latest News

  • PRECAUTIONS

    1. This is a single-use in vitro diagnostic reagent, do not reuse, and do not use expired products.

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  • LIMITATIONS OF THE TEST

    1. The test results of this kit are only for the reference of clinicians and should not be used as the sole basis for clinical diagnosis and treatment. Clinical management of patients should be considered in the context of their symptoms/signs, medical history, other laboratory tests and response to

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  • CE1434!Bioteke SARS-CoV-2 Antigen Test Kit has passed the CE certification

    Good news. Bioteke SARS-CoV-2 Antigen Test Kit has passed the CE certification.

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  • Antigen Test Kit Brochure

    SARS-COV-2 ANTIGEN TEST KIT IFU German.pdf

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  • Antigen test domestic market analysis

    ​Antigen test domestic market at present, the epidemic situation has been well controlled in my country, but with the advent of the epidemic period of respiratory infectious diseases in winter and spring, and the existence of imported epidemics overseas, the new crown epidemic in my country is in a state of sporadic outbreaks. In particular, local confirmed cases have appeared in many places recently, indicating that my country's new crown prevention and control is still in a tense period. My country has a large population and a high density of urban populations. The experience of multiple outbreaks shows that my country still needs convenient and fast new crown detection technology, and at the same time, it needs to greatly reduce the cost and the occupation of medical resources.

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   Telephone: 008651068501244

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  Email: info@bioteke.cn 

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