China Sky One Medical, Inc., one of the leading producers and distributors for external-Chinese medicine in China, has announced that the AMI Diagnostic Kit, Human Urinary Albumin Elisa Kit and Early Pregnancy Diagnostic Kit have passed the final stages of national inspection. These diagnostic kits will be issued new drug certificates and sold through drug stores, hospitals, examination stations and independent sales agents throughout China.
AMI Diagnostic Kit is used for early diagnosis of Myocardial Infarction (MI), also known as heart disease. All the test kits require users to place a blood or urine sample on the marker and a positive (+) or negative (-) reaction signal will result showing if they should consult their doctor for further testing. Several million people die from MI every year.
MI often occurs to people who are, but not limited to, smokers, over-weight and diabetic. There are approximately 8 million new MI patients in China every year. Recent medical studies have shown that heart failure or heart attacks are increasing among younger people in China. This is a result from a more modern life style, the fast pace of city life and increased pressure from work or school. The use of AMI Diagnostic Kits will help in early detection that can help in reducing these statistics.
Human Urinary Albumin Elisa Kit is used for early diagnosis of nephropathy, or kidney problems. According to the China Medical Newspaper, Early Kidney impairment does not give obvious symptoms, but causes irreversible impairments to the kidney. There are billions of people who suffer from diabetes, hypertension, cardiovascular disease and nephritis all over the world. This diagnostic kit was created by CSKI to inform users of any major changes their kidney may be experiencing.
Early Pregnancy Diagnostic Kit uses monoclonal antibody technology to inform users if they are pregnant. With this type of technology, a monoclonal antibody is created to specifically bind to a hormone, Human Chorionic Gonadotropin (HCG), which a pregnant woman produces after conception. This process allows for the detection of pregnancy.
In order for a drug to pass national inspection and granted a certificate of approval, the Company must complete the following procedures. First, the Company must submit an application for a new drug with the Heilongjiang Provincial Food and Drug Administration (PFDA) of the People's Republic of China.
The PFDA will then take a sample of the drug and send it to the National Biology Products Inspection Institute (NBPI) and the National Food and Drug Administration (NFDA) of the People's Republic of China for examination.
The Company will be granted a certificate to begin manufacturing and selling the product once it passes all testing requirements set forth by the respective agencies.
Source:佚名