Beijing Hyundai Gundam Biotech's 22 medical device registration certificates for testing kits have been cancelled

On September 14, the State Food and Drug Administration issued an announcement stating that, in accordance with the provisions of the "Measures for the Administration of Medical Device Registration", the medical device registration certificates of the following 22 products of Beijing Hyundai Gaoda Biotechnology Co.

The original text is as follows:

Announcement of the State Food and Drug Administration on the cancellation of medical device registration certificates (No.

In accordance with the "Administrative Measures for Medical Device Registration", the following 22 products of Beijing Hyundai Gundam Biotechnology Co.

Herpes simplex virus type II IgG antibody detection kit (enzyme-linked immunoassay), National Instruments Note 20153401229;

Toxoplasma antibody IgG detection kit (enzyme-linked immunoassay), National Instruments Note 20153401226;

Hepatitis E virus IgG antibody detection kit (enzyme-linked immunoassay), National Machinery Note 20163401044;

Herpes simplex virus type I IgG antibody detection kit (enzyme-linked immunoassay), National Instruments Note 20163402250;

Respiratory syncytial virus IgM antibody detection kit (enzyme-linked immunoassay), National Machinery Note 20173400372;

Chlamydia pneumoniae IgG antibody detection kit (enzyme-linked immunoassay), National Instruments Note 20173400374;

Mycoplasma pneumoniae IgG antibody detection kit (enzyme-linked immunoassay), National Instruments Note 20173400275;

Chlamydia pneumoniae IgM antibody detection kit (enzyme-linked immunoassay), National Machinery Note 20173400393;

Mycoplasma pneumoniae IgM antibody detection kit (enzyme-linked immunoassay), National Machinery Note 20173400296;

Hepatitis D virus IgM antibody detection kit (enzyme-linked immunoassay), National Machinery Note 20173400383;

Hepatitis E virus IgM antibody detection kit (enzyme-linked immunoassay), National Machinery Note 20173400543;

Hepatitis A virus IgM antibody detection kit (enzyme-linked immunoassay), National Machinery Note 20173400544;

Type II herpes simplex virus IgM antibody detection kit (enzyme-linked immunoassay), National Machinery Note 20173401189;

Rubella virus IgM antibody detection kit (enzyme-linked immunoassay), National Instruments Note 20173401182;

Toxoplasma IgM antibody detection kit (enzyme-linked immunoassay), National Instruments Note 20173401185;

Herpes simplex virus type I IgM antibody detection kit (enzyme-linked immunoassay), National Instruments Note 20173401184;

Cytomegalovirus IgM antibody detection kit (enzyme-linked immunoassay), National Instruments Note 20173401190;

Parvovirus B19 IgM antibody detection kit (enzyme-linked immunoassay), National Machinery Note 20173404150;

Parvovirus B19 IgG antibody detection kit (enzyme-linked immunoassay), National Instruments Note 20173404071;

Rubella virus IgG antibody detection kit (enzyme-linked immunoassay), National Instruments Note 20193401510;

Cytomegalovirus IgG antibody detection kit (enzyme-linked immunoassay), National Instruments Note 20183401940;

Mycobacterium tuberculosis IgG antibody detection kit (enzyme-linked immunoassay), National Instruments Note 20153401873