endotoxin testing medical devices price
|Xiamen Bioendo Technology, Co., Ltd. is a provider of in vitro diagnostic kits. We are the pioneer in the field of endotoxin detection by Tachypleus Amebocyte Lysate (TAL, LAL) reagents.
Limulus Amebocyte Lysate (LAL) test was commercially introduced as a pyrogen detection reagent for injectable medication in the late 1970’s. Compare to Rabbit Pyrogen Test, LAL tests are less time consuming, easy to perform and more reliable. Today, LAL tests are widely used by the pharmaceutical and medical device industries around the world to ensure that their products, e.g., intravenous drugs, vaccines, and medical devices, are free of bacterial endotoxin contamination.
LAL reagents extracted from the blue blood of North American horseshoe crab, Limulus polyphemus were commonly known as LAL and the reagents extracted from Chinese horseshoe crab, Tachypleus tridentatus, were commonly known as TAL. Both LAL and TAL have the same function for endotoxin detection. In USP 28 chapter 85 Bacterial Endotoxins Test, “Limulus Amebocyte Lysate (LAL) obtained from the aqueous exacts of circulating amebocytes of horseshoe crab (Limulus Polyphemus or Tachypleus tridentatus) which has been prepared and characterized for use as an LAL Reagent”, so we usually call the TAL Reagent as LAL Reagent.
The company located in the island city of Xiamen in Southeast China Sea, which you can see horseshoe crabs in the beaches during summer time.The company’s founder Wu Weihong started to produces LAL reagent in the late 1970’s. In 1983, the company became the first manufacturer licensed by China Food and Drug Administration to manufacture LAL for use as an endotoxin quality control test in the pharmaceutical and medical device markets.
For the past thirty years, different test methods were developed in the company to suit the requirements of different customers, for example: Gel Clot LAL is the simple positive/negative test often mentioned in pharmacopoeia monographs as the official referee test. Endotoxin-specific LAL does not react to (1,3)-ß-D-Glucan, it is used in the samples that have the possibility to be contaminated with (1,3)-ß-D-Glucan. Chromogenic Endpoint LAL assay provides quantitative rests without expensive equipment and software. Kinetic Turbidimetric LAL is the economical choice for large volume of samples’quantitative assay. Kinetic Chromogenic LAL is the most sensitive LAL method and provides wider assay range. The company also provides various endotoxin detection accessory products, such as pyrogen-free labware, test buffers, laboratory equipment for the customers’ conveniences.
CFDA cleared clinical diagnostic reagents Fungi (1,3)-β-D-glucan Assay Kit identifies.
Invasive Fungal Disease (IFD) early in the disease process and Endotoxin Assay Kit for Human Plasma could be used to diagnostic sepsis in early stage.
We always feel that all success of our company is directly related to the quality of the products we offer. They meet the highest quality requirements as stipulated in ISO9001:2008, ISO13485:2003 guidelines and our stringent quality control system.
Today, the company owns a new GMP conformed manufacture facility that continues to provide different kinds of in vitro diagnostic kits which includes the diagnostic of infections and tumors to meet the needs of its valued customers in different countries.
• In 1979, Program of “LAL Research and Manufacture” was rewarded the provincial Magnificent Innovation Award.
• In 1982, the film Blue Blood (founder Wu Weihong authored) was rewarded the Golden Fringe Award from Food and Agriculture Organization of the United Nations.
• In 1983, Program of “LAL Reagent Manufacture Process and Quality Control” was rewarded the first grade Chinese Health Ministry Innovation Award.
• In 1988, Program of “Applied Research on LAL Test” was rewarded the Chinese Health Ministry Science and Technology Advancement Award.
• In 1995, the company commercialized the endotoxin-specific LAL for the first time in China.
• From 1983 to 1997, “Disquisition Compilations on Horseshoe Crab and LAL Test” series 1 to 4, edited by founder Wu Weihong, were published. The compilations have been the most referenced publications by Chinese scientist and researchers in the field.
• From 1982 to 2007, the company hosted dozens of training and education programs on LAL test across China.
• In 2005, the company commercialized the chromogenic LAL assay kit in China, the SOP was cited by Chinese pharmacopoeia.
• In 2011, the company’s project “Diagnosis of Gram Negative Bacterial Infection by Chromogenic LAL” received Innovation fund from the Ministry of Science and Technology.
In 2013, “Bacterial Endotoxin and Fungi (1,3）-ß-D-glucan Detection System” became one of the Xiamen marine economic development of regional innovation and demonstration projects.
endotoxin testing medical devices price