Supplier
This supplier has been verified onsite by world-leading inspection company,
TüV SüD
Verified onsite by world-leading inspection company, TUV-SUD Group
2019.01.27
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Beijing Bioneovan Co.,Ltd. comes from corporate restructuring of Beijing Sihuan Biopharmaceutical Co.Ltd., a holding subsidiary of a listed company named Jiangsu Sihuan Bioengineering Co.Ltd.in 2005. Sihuan Biopharmaceutical Co.,Ltd. founded in 1988 ,once an affiliated enterprise of the Academy of Military Medical Sciences, is one of the earliest high-tech companies engaged in researching, developing, producing and marketing of gene engineering medicines and diagnostic reagent. A new factory with 1500m2 workshop for professionally manufacturing vitro diagnostic reagent was built in the Daxing Overseas Students Pioneer Park located in Daxing Industrial Development Zone,Beijing in2005,and fully certified GMP plan in2008. We promoted and apply certification ISO9001:2008 quality management system, ISO13485-2003 quality management system and CE certification in 2009. All of the work was under standardized management. We specialize in R&D, producing and marketing of vitro diagnostic reagents .There are eleven registered approval numbers possessed such as five items of hepatitis B, ELISA kit for antibody to hepatitis C virus, Rapid Test for antibody to Human Hepatitis C Virus(Colloidal Gold), Group A Rotavirus Antigen Rapid Test Kit , ELISA kit for antibody IgM to hepatitis E virus, and ELISA kit for antibody IgG to hepatitis E virus at present ,and more than 30 scientific research products.
5.0/5
Very satisfied
2 Reviews
  • Transaction level
  • 8 Transactions
    10,000+
  • Response Time
    <24h
  • Response Rate
    80.7%

PRODUCT CAPACITY

Production Flow

Production Equipment

Name
No
Quantity
Verified
Acidity Meter
LIDA
1
Analytical Balance
JA2003
5
Automatic Ruling Machine
No Information
1
High Speed Refrigerated Centrifuge
GL-21M
1
Automatic Printer
PL-2000
1
Automatic Coating Machine
No Information
1
Verified

Factory Information

Factory Size
3,000-5,000 square meters
Factory Location
Floor 2 And 3, Building 3, No. 27, Yongwang Road, Daxing Biomedical Industry Base, Zhongguancun Tech Park, Daxing District, Beijing City,China
No. of Production Lines
Above 10
Contract Manufacturing
OEM Service OfferedDesign Service OfferedBuyer Label Offered
Annual Output Value
US$1 Million - US$2.5 Million

Annual Production Capacity

Product Name
Production Line Capacity
Actual Units Produced(Previous Year)
Verified
Noro virus Rapid Test
400,000 Tests Per Month
4,000,000 Tests
Group A Strep Tococcus Rapid Test
400,000 Tests Per Month
4,000,000 Tests
HAV IgM Elisa Kit
2,000 Kits Per Month
20,000 Kits
HEV IgM Elisa Kit
2,000 Kits Per Month
20,000 Kits
Hepatitis C Core Antigen Elisa Kit
2,000 Kits Per Month
20,000 Kits
Verified

Production Line

Production Line
Supervisor
NO.of Operators
NO.of In-line QC/QA
Verified
Prodcut line for Elisa
2
8
2
Verified

QUALITY CONTROL

Test Equipment

Machine Name
Brand & Model NO
Quantity
Verified
Micrometer
WSH0-25mm 0.001mm
5
Caliper
Shanghai 0.02mm
5
Microplate Reader
Thermo
1
Automatic Enzyme Label Washing Machine
DEM-3
1
Verified

R&D CAPACITY

Production Certification

Picture
Certification Name
Certified By
Business Scope
Available Date
Verified
CE
Other
2015-08-26 ~ 2020-08-25
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Rapid test for detection of CVA16-IgM Antibodies (Colloidal Gold)
2017-12-26 ~ 2019-12-25
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Rapid test for detection of EB-IgM Antibodies (Colloidal Gold)
2017-12-26 ~ 2019-12-25
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Rapid test for Antibody to Treponema Pallidum (Colloidal Gold)
2017-12-26 ~ 2019-12-25
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Rapid test for Rotavirus and Adenovirus Antigen (Colloidal Gold)
2017-12-26 ~ 2019-12-25
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Diagnostic Kit for Antibody to Hepatitis B Surface Antigen(Elisa)
2017-12-26 ~ 2019-12-25
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Diagnostic Kit Hepatitis B e Antigen (Elisa)
2017-12-27 ~ 2019-12-26
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Diagnostic Kit for IgM Antibody to CBV (Elisa)
2017-08-06 ~ 2019-08-05
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Diagnostic Kit for IgA Antibody to EBV-VCA (Elisa)
2017-08-03 ~ 2019-08-02
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Diagnostic Kit for IgM Antibody to Hepatitis A Virus(Elisa)
2017-08-03 ~ 2019-08-02
CE
ENTE CERTIFICAZIONE MACCHINE
Elisa kit & Rapid test Elisa kit: HAV-IgM HEV-IgG HEV-IgM EBV-IgA Rapid test: Rotavirus| Rota/Adeno virus (2 in 1)| Tuberculosis(TB)-IgG antibody| Treponema Pallidum(TP) antibody| HAV-IgM| HEV-IgG| HEV-IgM| Epstein Barr(EB)-IgM antibody| Helicobacter pylori Antigen| Helicobacter pylori Antibody| Chlamydia pneumoniae(Cpn)-IgM antibody| Mycoplasma Pneumoniae(MP)-IgM| Mycoplasma Pneumoniae(MP)-IgG|enterovirus 71 (EV71)-IgM antibody| Coxsackie Virus A16 (CVA16)-IgM antibody| Fecal Occult Blood (FOB)|Typhoid IgG/IgM| Dengue IgG/IgM| Malaria Antigen pf/pv
2015-06-25 ~ 2020-06-24
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Rapid test for Human Antibody IgG of Cytomegalovirus, Rubella, Herpes Simplex-II, Toxoplasma (Colloidal Gold)
2017-12-27 ~ 2019-12-26
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Diagnostic Kit for Antibody to Hepatitis B e Antigen (Elisa)
2017-12-26 ~ 2019-12-25
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Diagnostic Kit for IgM Antibody to Hepatitis C Core Antigen (Elisa)
2017-08-03 ~ 2019-08-02
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Rapid test for Human Antibody IgM of Cytomegalovirus, Rubella, Herpes Simplex-II, Toxoplasma (Colloidal Gold)
2017-12-27 ~ 2019-12-26
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Rapid test for detection of MP-IgG Antibodies (Colloidal Gold)
2017-12-26 ~ 2019-12-25
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Diagnostic Kit for IgM Antibody to Hepatitis E Virus (Elisa)
2017-08-03 ~ 2019-08-02
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Diagnostic Kit for Human Parvovirus B19 IgG Antibody (Elisa)
2017-08-03 ~ 2019-08-02
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Diagnostic Kit for IgG Antibody to Hepatitis E Virus (Elisa)
2017-12-27 ~ 2017-12-26
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Diagnostic Kit for IgM Antibody to Human Parvovirus B19 (Elisa)
2017-08-03 ~ 2019-08-02
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Diagnostic Kit for IgM Antibody to CBV (Colloidal Gold)
2017-12-26 ~ 2019-12-25
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Rapid test for detection of CPN-IgM Antibodies (Colloidal Gold)
2017-12-27 ~ 2019-12-26
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Rapid test for detection of EV71-IgM Antibodies (Colloidal Gold)
2017-12-26 ~ 2019-12-25
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Rapid test for IgM Antibody to Hepatitis A Virus (Colloidal Gold)
2017-12-27 ~ 2019-12-26
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Rapid test for detection of MP-IgM Antibodies (Colloidal Gold)
2017-12-26 ~ 2019-12-25
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Rapid test for detection of HP Antigen (Colloidal Gold)
2017-12-27 ~ 2019-12-26
P.R. China Certificate for Exportation of Medical Products
Food and Drug Administration of Beijing Daxing District
Diagnostic Kit for Antibody to Hepatitis B Core Antigen (Elisa)
2019-12-26 ~ 2019-12-25
Verified

Certification

Picture
Certification Name
Certified By
Business Scope
Available Date
Verified
ISO13485
ENTE CERTIFICAZIONE MACCHINE
Production, sale and service of In Vitro Diagnostic reagents of Elisa kit (e.g. HAV-IgM, HBv, HEV-IgG, anti-HCV, HIV, EBV[VCA]-IgA) and colloidal Gold test (HbsAg rapid test, HCV rapid test, Rotavirus rapid test, Helicobacter pylori Ag rapid test.)
2015-08-26 ~ 2020-08-25
GMP
State Drug Administrition
Extrinsic Diagnostic Tests
2006-05-17 ~ 2015-05-16
Verified

Research & Development

5 - 10 People