SHINJIN MEDICS INC.

TKC-ACTH-RIACT (Endocrine Hormones and Peptides Test Reagents),
TKC-PTH-RIACT (Bone Components Metabolism Test Reagents),
TKC-ESTR-RIACT (Blood Pregnant Birth Hormones and Proteins Test Reagents)

Acquired the certification of KGMP
(Reg. No KCL-CBBA-14440)

Laboratory develops RIAKEY 25 OH Vitamin D3 RIA Tube (MFDS Reg. No 21-4886)

Laboratory develops DIAKEY Dengue combo NS1&IgM/IgG Rapid Test (MFDS Reg. No 21-672)

Acquired the certification of EN ISO 13485:2016
(Q5 050097 0020) (NB:TÜV SÜD)

Laboratory develops RIAKEY Thyroglobulin IRMA TubeII (MFDS Reg. No 21-4127)

Laboratory develops RIAKEY Total 25OH Vitamin D RIA Tube (MFDS Reg. No 20-5162)

Acquired the E.A.R certificate (KS 0478-2020)
(NB: Obelis S.A)

Acquired the certificate of IVD notification (KS 0477-2020) (NB: Obelis S.A)

Laboratory develops DIAKEY COVID-19 Ag Rapid Test
(MFDS Reg. No 20-942)

Laboratory develops DIAKEY COVID-19 IgM/IgG Rapid Test (MFDS Reg. No 20-383)

Laboratory develops DIAKEY REALcheck COVID-19(nCOV) Detection Kit (MFDS Reg. No 20-406)

Laboratory develops DIAKEY REALcheck Viral DNA, RNA Prep Kit (MFDS Reg. No. 20-455)

CE evaluation (PSA) (V1 050097 0019) (NB:TÜV SÜD)

Laboratory develops MASSIA R4200 (MFDS Reg. No 18-5081)

Laboratory develops RIAKEY Anti GAD IRMA (MFDS Reg. No 18-4722)

Laboratory develops RIAKEY Intact PTH IRMA Tube (MFDS Reg. No 18-4584)

Renewal review: ISO13485: 2012 → ISO 13485: 2016

Laboratory develops RIAKEY IGFBP-3 IRMA Tube II (MFDS Reg. No 18-4274)

RIAKEY hGH Obtain medical device certification

Laboratory develops E2600 (KFDA Reg. No 17-303)

Laboratory develops RIAKEY Total IgE IRMA Tube II (KFDA Reg. No 17-44)

Laboratory develops E2600

RIAKEY Aldosterone, Anti-TPO, hGH, IGF-1, IGF-BP3, Testosterone, Tg Ab, TR Ab, UBC Obtain medical device permission

GMP renewal

DIAKEY Ferritin, FSH Development and Medical Device Authorization

The company acquired CFDA (China Food and Drug Administration) registration.

Laboratory develops MASSIA

GMP renewal

Expansion of diagnostic reagent production plant

Our web site renewal.

Declared VISION 2020

Selected as support for export capacity enhancement projects hosted by Gyeonggi-do Ministry of SMe.

E-Frontier Company selected by Gyeonggi Small and Medium Business Support Center

Laboratory develops DREAM GAMMA HEs

Dream Gamma 10 (MESSIAH Gamma Counter) Acquisition of domestic item permission for gamma counter

The diagnostic reagent manufacturing factory was expended.

The diagnostic instrument development laboratory achieved development of Gamma counter.

SHINJIN Medics establishes diagnostic instrument development laboratory.

The laboratory developed DIAKEY H.Pylori for ELISA.

RIAKEY HBeAg/Ab, Anti-HBcIgM RIA were developed.

The company acquired CE Mark.

Laboratory develops RIAKEY Anti-HBc RIA.

The company is certified as a qualified corporation in accordance with KGSP (Korea Good Supplying Practice) by MFDS (Ministry of Food & Drug Safety, Republic of Korea).

DIAKEY HBsAg, Anti-HBs, Anti-HCV 3.0, Anti-HIV1/2 Kit development

사업소 이전(경기 고양 일산구 백석동 1141-1 일산테크노타운B504)

RIAKEY FSH, LH, Prolactin, CEA, TSH Factory

SHINJIN Medics Inc, receives approval for ISO 9001(International Standardization Organization 9001) by the BS (British Standards Institution) of the United Kingdom.

SHINJIN Medics establishes the manufacturing factory as well as laboratories to B405 Ilsan-technotown 1141-1 Baeksuk-dong Ilsan-gu Goyang-city Gyeonggi-go, Republic of Korea.

경기도 고양시 일산구 백석동 아파트형 공장 분양

SHINJIN Medics is listed as Venture Entrepreneur at Ministry of Small and Medium Business Administration and increased the Paid Capital by about 1.4millon dollors. The company is assigned the Contract for Research and Development of the 4 different kind RIA kits by the Ministry of Commerce, Industry and Energy. Also, our laboratory develops our first RIA diagnostic kit to screen and monitor tests for Hepatitis, Tumor Markers.

The head office of SHINJIN Medics and Laboratories moved to 830-71 Injung Bldg. Yeoksam-dong Gangnam-gu, Seoul.

Our laboratory introduces our first commercial products for Radioimmunoassay (RIA) diagnostic kits, HBsAg, Anti-HBs and AFP, registered as RIAKEY for RIA.

It is assigned the Contract for Research and Development of the 32 different kinds of RIA kits by the Ministry of Science and Technology.

SHINJIN Medics Laboratories is initially founded on 834-20 O&T Bldg. Yeoksam-dong Gangnam-gu, Seoul.

The company receives the Certificate for Manufacturing Industry and the License for Handling of Radioisotope.

SHINJIN Medics Inc. is founded on 832-6 Yeoksam-dong Gangnam-gu, Seoul.

The company obtains the Business Licenses for Import, Distributor, Wholesales and retails and receives the Special License for the Sales of RIA products.