Rapid Test, Rapid Extraction, Covid 19 Test Manufacturer & Supplier

Certification: ISO9001, ISO13485, ISO11737, CE

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 2022, 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

The company was founded in 2005

More than 51 authorized patents

The factory covers an area of more than 50000 square meters

It has more than 600 employees and technicians

Patent technology

By 2022, Bioteke has 51 authorized patents and 12 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 600 employees and covers a factory area of more than 50000 square meters.

SARS-CoV-2 Detection Solution

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

SAMPLING

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 ...

EXTRACTION

DETECTION

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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Application Scenario Display

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

BioTeke wins in the countersuit against section 337 from USA !

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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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Again！Bioteke Sterile Disposable Virus Sampling Kit has passed the US FDA 510K

Recently, Bioteke Sterile Disposable Virus Sampling Kit has passed the US FDA 510K registration with its excellent preservation performance and high virus detection sensitivity. After obtaining the EU CE certification, UK MHRA registration, Canada MDEL, Brazil certification, Saudi Arabia certificati

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SARS-CoV-2 Antigen Test Kit Instruction for use

Instruction for Use.pdf

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Maintenance methods for PCR machines

PCR machine is an extremely important tool for molecular biology research. It is a molecular biology technique used to amplify specific DNA fragments, and the basic principle is to simulate DNA replication in cells in a test tube, that is, to create artificial nucleic acid semi-conserved replication conditions, so that the process of amplification of the target DNA is completed outside the cell, and PCR machine can be regarded as a special DNA replication outside the organism. So how can we maintain the PCR machine?

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