Certificates

Factory Certification

The following is the qualification certificate of our factory: NewScen Coast Bio-Pharmaceutical Co., Ltd.

Click thumbnails to see the details

MHRA

Products: PCT, CRP, AFP, CEA, cTnI, D-Dimer, mAlb, TSH, HCG, LH, FSH, SF, FOB, HIV, HCV

Certificate: CE

Issue Date: 2022/04/28

Expiry Date: Indefinite

Issued By: MHRA

Method: Lateral Flow Assay (Immunochromatography Assay)

ECrep (IVDDย 8others&5ST)
ECrep (IVDDย ListAย 30829&65847)
ECrep (IVDDother-COVID-65756)
ECrep (IVDDotherย COVIDย IgGIgMย 64839)
NewScen List

RIOMAVIX

Products: ย MDT, CHIK IgG/IgM, ZIKA IgG/IgM, ZIKA NS1Ag, DEN IgG/IgM, DEN NS1 Ag,

MAR Pf/Pan, HPAb, HPAg, TB, TF, TP

Certificate: CE

Issue Date: 2022/03/08

Expiry Date: Indefinite

Issued By: RIOMAVIX

Method: Lateral Flow Assay (Immunochromatography Assay)

One Step Multiple Drug Test
Chikungunya IgG+IgM Rapid Test
Zika Virus IgG+IgM Rapid Test
Zika NS1 Antigen Rapid Test
Dengue IgG+IgM Rapid Test
Dengue NS1 Antigen Rapid Test
Malaria Pf+Pan Antigen Rapid Test
H.Pylori (HP) Antibody Rapid Test
H.Pylori (HP) Antigen Rapid Test
M.Tuberculosis (TB) Antibody Rapid Test
Transferrin (TF) Rapid Test
Treponema Pallidum (TP) Antibody Rapid Test

NMPA

Products: HIV, HCV, TP, TB, HPAg, HPAb, FOB, SFย 

Certificate: NMPA

Issue Date:ย  HIV 2019/04/08, HCV 2021/01/12, TP 2020/07/01, TB 2019/04/08,

HPAg/HPAb 2022/06/29, FOB/SF 2022/06/19

Expiry Date: HIV 2024/04/07, HCV 2026/01/11, TP 2025/06/30, TB 2024/04/07,

HPAg/HPAb 2027/06/28, FOB/SF 2027/06/18

Issued By: NMPA

Method: Lateral Flow Assay (Immunochromatography Assay)

HIV NMPA
HCV NMPA 2021-2026
TP NMPA
TB NMPA
HPAg NMPA 2022-2027
HPAb NMPA 2022-2027
FOB NMPA 20220619-20270618
SF B NMPA 20220619 20270618
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