[Company Information]

Name : RapiGEN Inc.
Website Address : http://www.rapigen-inc.com/en/
Location
- Headquarters : 2F, 25, Heungan-daero, Gunpo-si, Gyeonggi-do, Republic of Korea
- Research Center : F, 25, Heungan-daero, Gunpo-si, Gyeonggi-do, Republic of Korea
- Manufacturing Plants : F, 25, Heungan-daero, Gunpo-si, Gyeonggi-do, Republic of Korea

Contacts Department
Contacts : Sales and Marketing Department
Phone: +82 31 427 4677
Fax: +82 31 427 4678
Email: sales1@rapigen-inc.com, sales5@rapigen-inc.com

Manufacturer Information :
RapiGEN Inc. has been a leading Rapid Diagnostic Test kit (RDT) producer, well-known as the pioneer of introducing and applying its unique black gold particle technology on RDT products, with the enhanced specificity, sensitivity and reproducibility compared to previous RDT products. With 10 years of commitment on R&D, the core gold-colloid technology has been being continuously improved and applied to a wide variety of human and veterinary RDT products.
RapiGEN Inc.‘s facility complies with ISO 9001 and 13485, achieved CE certificate for variety of products and topped in WHO Malaria Round 6 evaluation. All products are produced under KGMP rules and under strictly controlled conditions for consistency in product quality.
With the unique black gold technology, RapiGEN Inc. aims at customer satisfaction by distinctive and exceptional product quality.

[Medical Device Information]

Product 1
Name : BIOCREDIT Malaria Ag Pf (HRPII)
Intended Use : RapiGEN BIOCREDIT Malaria Ag Pf (HRPII) test is an immunochromatographic assay for detection of Malaria P. falciparum histidine rich protein II (HRPII).
- Control Line : Purple/Red
- Test Line: Black
- Pf Sensitivity : 98.5%
- Specificity : 98.6%
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Product 2
Name : BIOCREDIT Malaria Ag Pf/Pan (HRPII/pDLH)
Intended Use : RapiGEN BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) test is an immunochromatographic assay for detection of HRPII specific to P. falciparum and Plasmodium lactate dehydrogenase (pLDH) in whole blood.
- Control Line : Purple/Red
- Test Line: Black
- Pf Sensitivity : 99.5%
- Non-Pf Sensitivity : 96%
- Specificity : 99.6%
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Product 3
Name : BIOCREDIT Malaria Ag Pf/Pv (HRPII/pDLH)
Intended use : RapiGEN BIOCREDIT Malaria Ag Pf/Pv (HRPII/pDLH) test is an immunochromatographic assay for the qualitative detection and differentiation of P. falciparum and P. vivax from Plasmodium spp. in human whole blood.
- Control Line : Purple/Red
- Test Line: Black
- Pf Sensitivity : 98.7%
- Pv Sensitivity : 99.2%
- Specificity : 99.6%
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Product 4
Name : BIOCREDIT Dengue NS1 Ag
Intended use : RapiGEN BIOCREDIT Dengue NS1 test is an immunochromatographic assay to detect dengue virus NS1 antigen in human blood.
- Control Line : Purple/Red
- Test Line: Black
- Diagnosis : Early clinical phases of dengue infection
- Sensitivity : 98.5%
- Specificity : 98.6%
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Product 5
Name : BIOCREDIT Dengue IgG/IgM
Intended use : RapiGEN BIOCREDIT Dengue IgG/IgM test is an immunochromatographic assay for detection of antibodies (IgG & IgM) to dengue virus in human blood.
- Control Line : Purple/Red
- Test Line: Black
- IgG Sensitivity : 99.2%
- IgM Sensitivity : 99%
- Specificity : 99.5%
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Product 6
Name : BIOCREDIT HBs Ag
Intended use : RapiGEN BIOCREDIT HBs Ag test is an immunochromatographic assay for detection of Hepatitis B surface antigen in human serum.
- Control Line : Purple/Red
- Test Line: Black
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Product 7
Name : BIOCREDIT HIV 1/2 Ab
Intended use : RapiGEN BIOCREDIT HIV 1/2 Ab test is an immunochromatographic assay for detection of Human Immunodeficiency Virus type 1 and 2 antidobies (IgM, IgG and IgA) in human blood.
- Control Line : Purple/Red
- Test Line: Black
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Product 8
Name : BIOCREDIT H. pylori Ag
Intended use : RapiGEN BIOCREDIT H. pylori Ag test is an immunochromatographic assay for detection of Helicobacter pylori antigen in human fecal specimens.
- Control Line : Purple/Red
- Test Line: Black
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Product 9
Name : RapiGEN CPV Ag
Intended use : RapiGEN CPV Ag test is an immunochromatographic test for qualitative detection of canine parvovirus antigen in canine feces.
- Control Line : Purple/Red
- Test Line: Black
- High Limit of Detection
- Sensitivity : 99.5%
- Specificity : 99%
- Specimen : fecal swab
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Product 10
Name : RapiGEN CDV Ag
Intended use : RapiGEN CDV Ag test is an immunochromatographic test for qualitative detection of canine distemper virus in canine.
- Control Line : Purple/Red
- Test Line: Black
- High Limit of Detection
- Sensitivity : 98%
- Specificity : 98%
- Specimen : Eye discharge (conjunctiva), Serum, Plasma
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