Confidence, Honesty and Innovation
Bioteke Corporation, which focuses 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 authorized patents and 12 software copyrights.
As a "National High-tech Enterprise" , Bioteke has passed ISO13485 Quality Management System Certification.
Bioteke holds the philosophy to offer products with low price, high quality and superior services to the world, and insists on pursuing higher excellence.
Focusing on rapid nucleic acid detection and POCT rapid detection, Bioteke offers kinds of lab instruments as: virus sampling collection, automatic nucleic acid extractor, PCR machine, and disinfecting apparatus. And it also provide many kinds of reagents & kits.
BioTeke Corporation is the factory Of
Real-time Fluorescence PCR Analyzer
Disposable Virus Sampling Swab Kits
SARS-CoV-2 antigen test kit
Multiple Respiratory Multipathogen antigen test kit
Automated Nucleic Acid Extraction System
Sample Transfer Processing System
Nucleic Acid Detection Reagent
Nucleic Acid Extraction Reagent
More than 100 kinds of DNA/RNA Extraction kits
| 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/ FDA Registration/ 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/ FDA Registration/ 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/ FDA Registration/ 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/ FDA Registration/ 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 |
Telephone: 0086 18115363743
Email : zr@bioteke.cn
