ABOUT US


ABOUT PRIME4DIA

 

PRIME4DIA is R&D group and manufacturer for in vitro diagnostic products from South Korea. PRIME4DIA is focusing its efforts on Point of Care Testing (POCT) as its core strategic business. PRIME4DIA is developing proprietary and unique core technologies for the development of world class rapid immunochromatographic assay and ELISA systems. PRIME4DIA has established its unique position in the IVD industry as a total solution provider for all kind of rapid test raw materials and semi-finished products. Our R&D center and factory located at Anyang city, nearby Seoul, is an up-to-dated manufacturing facility equipped to produce monoclonal antibody, gold nanoparticle and wide range of rapid tests (semi-finished products).

OVERVIEW

As a company specializing in the development, production, and manufacturing of point-of-care diagnostic kits (POCT), we are expanding into the mobile healthcare market based on our main products (influenza and dengue fever diagnostics) and proprietary products (HIV 4th generation diagnostic kits, high-sensitivity kits, etc.).

* Company name: Primepodia
* Representative : Kyu-Ha Oh
* Establishment Date: April 21, 2016
* Business field: development and production of on-site diagnostic kits (POCT)
                              Core technology transfer
                              Antigen and antibody development and production

HISTORY

2020

May. 29    P4DTECT COVID-19 lgM/lgG CE registration
May. 18    P4DTECT COVID-19 lgM/lgG export manufacturing
                  license
Apr. 27     ISO 13485:2016 certified
Apr. 20     Small and Medium Business Certification Renewal
Feb. 03     Participated in MEDLAB, Dubai Medical Equipment
                  Exhibition
Jan. 27     Participated in ARAB HEALTH, Dubai Medical
                  Equipment Exhibition

2019

Dec. 18     Report on change of accreditation of research
                   institute affiliated with company
Nov. 23     Venture company recognition renewal
Nov. 18     Participated in German medical equipment
                  exhibition MEDICA
Nov. 05     Participated in China International Import Expo
Oct. 31    Recognized as a small business
Jul. 25     P4DETECT Dengue Combo export manufacturing
                 license
Jul. 25     P4DETECT Dengue NS1 export manufacturing
                 license
Jul. 24     Medical device GMP certification (consignment
                 manufacturer)
Jul. 11     P4DETECT Dengue gM/lgG export manufacturing
                 permission
Jul. 10     Medical device manufacturing permission
Feb. 04     Participated in MEDLAB, Dubai Medical Equipment
                  Exhibition

2018 ~ 2016

Nov. 12     Participated in German medical equipment
                   exhibition MEDICA
May 29     First accreditation of company-affiliated research
                  institute
Feb. 07     Participated in MEDLAB, Dubai Medical Equipment
                  Exhibition

Nov. 23     Venture company recognition
Nov. 13     Participated in German medical equipment
                   exhibition MEDICA

Apr. 21     Established Primepodia Co., Ltd.


‌CERTIFICATE

Venture company confirmation

 

Small business confirmation

 

Corporate R&D Center

 

KGMP

 

Certificate of EU product notification

 

ISO 13485 : 2016

 

Certificate of Free Sales
(Dengue  IgM/IgG)
(Dengue NS1)
(Dengue Combo)

 

Certificate of Free Sales
(COVID-19 IgM/IgG)