Manufacturer's By Device SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassay-SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassay

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
SD Biosensor Inc.C-4th&5th 16 Deogyeong-daero 1556beon-gil Yeongtong-gu Suwon-si Gyeonggi-do 16690 Republic of Korea

Suwon-si
16690

South Korea
MT Promedt Consulting LtdBeaver House 23-38 Hythe Bridge Street

Oxford
OX1 2EP

England United Kingdom
05/11/202114605
Shenzhen Microprofit Biotech Co. LtdRm. 405 406 Zone B /4F Rm. 205 206-1 207 West Side of Zone B/ 2F Haowei Building No. 8 Langshan 2nd Road
Songpingshan Songpingshan Community Xili Street Nanshan District
Shenzhen
518057

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
03/19/202112785