Manufacturer's Devices - BioTeke Corporation (Wuxi) Co. Ltd

Address:




4th Floor D5 & 2nd Floor D3 & 1st and 2nd Floor D16 No. 1719 Huishan Avenue Wuxi



Jiangsu Province

214174

China


Authorised Representative/ UK Responsible Person
Name: SUNGO Certification Company Limited
Address:

3rd Floor 70 Gracechurch Street



London

EC3V 0HR

England United Kingdom




Code/Term Type
Oral/upper respiratory tract specimen collection swabOral/upper respiratory tract specimen collection swabClass I
General specimen collection kit IVD clinicalGeneral specimen collection kit IVD clinicalIVD General
Nucleic acid sample preparation instrument IVDNucleic acid sample preparation instrument IVDIVD General
Nucleic acid extraction/isolation kit IVDNucleic acid extraction/isolation kit IVDIVD General
SARS-CoV-2 neutralizing antibody IVD kit rapid ICT clinicalSARS-CoV-2 neutralizing antibody IVD kit rapid ICT clinicalIVD General
Monkeypox virus nucleic acid IVD kit nucleic acid technique (NAT)Monkeypox virus nucleic acid IVD kit nucleic acid technique (NAT)Class I
Monkeypox virus nucleic acid IVD kit nucleic acid technique (NAT)Monkeypox virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General