THE Food and Drug Administration (FDA) has warned the public against the use of unregistered diagnostic tests made by a China-based biomedical company.

In an advisory dated Sept. 10, the agency said the public should avoid buying and using diagnostic devices from Shenzhen New Industries Biomedical Engineering (Snibe) Diagnostic. These equipment are used to test for hepatitis B, hepatitis C, and the human immunodeficiency virus (HIV).

The products are the Snibe Diagnostic Maglumi medical devices for HIV antigen/antibody Combi, hepatitis B surface antigen, hepatitis B surface antibody, hepatitis C antibody, and syphilis.

These diagnostic tests do not have a certificate of product registration, according to the FDA.

“Since these unregistered medical devices have not gone through the evaluation process of the FDA, the agency cannot assure its quality and safety,” according to the advisory signed by FDA officer-in-charge Rolando Enrique D. Domingo.

The FDA warned businesses against selling and advertising these products from Snibe Diagnostic. It also asked the Bureau of Customs to stop the entry of these products.

“All concerned establishments are warned not to distribute, advertise, or sell the said violative medical devices until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued,’ the FDA said.

One of 10 Filipinos have chronic hepatitis B while six of 1,000 have chronic hepatitis C, according to the World Health Organization. The Department of Health reports 40 new cases of HIV everyday. — Gillian M. Cortez