Question 1

How many devices does Zhongshan Bio-Tech Co., Ltd. have in the registry?

Accepted Answer

The registry currently lists 20 devices for Zhongshan Bio-Tech Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Question 2

Which registries list Zhongshan Bio-Tech Co., Ltd.'s devices?

Accepted Answer

Among its 20 most recently registered devices, Zhongshan Bio-Tech Co., Ltd. has devices listed in EUDAMED (20 devices).

Question 3

What risk classes do Zhongshan Bio-Tech Co., Ltd.'s devices fall under?

Accepted Answer

Among its 20 most recently registered devices, the classes recorded for Zhongshan Bio-Tech Co., Ltd.'s devices are IVD general and IVD devices for self-testing. Each device page shows its own class and authorisation.

Question 4

What are the newest devices from Zhongshan Bio-Tech Co., Ltd. in the registry?

Accepted Answer

The most recently registered devices listed for Zhongshan Bio-Tech Co., Ltd. include Detection Kit for Severe Fever with Thrombocytopenia Syndrome Virus IgG (ELISA), Detection Kit for EB Virus Capsid Antigen (VCA) IgA Antibody (ELISA), Detection Kit for Plasmodium Falciparum Histidine-rich Protein II (HRP-II) (Immunochromatography Assay) and Detection Kit for EB Virus Nuclear Antigen 1 (NA1) IgA Antibody (ELISA).

Zhongshan Bio-Tech Co., Ltd.

Catalogue20

Detection Kit for Severe Fever with Thrombocytopenia Syndrome Virus IgG (ELISA) Ref FR0101-96

Detection Kit for EB Virus Capsid Antigen (VCA) IgA Antibody (ELISA) Ref EB0105-96

Detection Kit for Plasmodium Falciparum Histidine-rich Protein II (HRP-II) (Immunochromatography Assay) Ref EX0402-25

Detection Kit for EB Virus Nuclear Antigen 1 (NA1) IgA Antibody (ELISA) Ref EB0103-96

Detection Kit for Alpha Fetoprotein (ELISA) Ref JT0101-96

Detection Kit for EB Virus Zta Protein IgA Antibody (ELISA) Ref EB0101-96

COVID-19 Antigen Rapid Testing Kit Ref XG030311

Detection Kit for Falciparum Malaria/Vivax Malaria LDH (Colloidal Gold Method) Ref EX0301-25

Detection Kit for Influenza A Virus Antigen (Colloidal Gold Method) Ref JL0301-25

COVID-19 Antigen Rapid Testing Kit (Colloidal Gold) Ref XG0310-01

Detection Kit for Hepatitis E Virus IgM Antibody (Colloidal Gold Method) Ref WG0301-20

Detection Kit for Carcino-embryonic Antigen (ELISA) Ref AP0101-96

COVID-19 Antigen Rapid Testing Kit (Colloidal Gold) Ref XG0310-10

Detection Kit for Falciparum Malaria/Vivax Malaria LDH (Immunochromatography Assay) Ref EX0401-25

Detection Kit for Severe Fever with Thrombocytopenia Syndrome Virus IgM/IgG Antibody (Colloidal Gold Method) Ref FR0301-25

2019-nCoV Antigen Test (Lateral Flow Method) Ref XG030312

Quantitative Diagnostic Kit for Procalcitonin (PCT) (Colloidal Gold Method) Ref JG0301-25

Diagnostic Kit for Antibody to Treponema Pallidum (ELISA) Ref MD0101-96

Detection Kit for Hepatitis E Virus IgM Antibody (ELISA) Ref WG0101-96

COVID-19 Antigen Rapid Testing Kit (Colloidal Gold) Ref XG0303001

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