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FDA approval. And why is it so important?
High-performance tissue culture incubators with hot air sterilisation
Work today on the cell cultivation of tomorrow.

FDA approval. And why is it so important?

The FDA is responsible for the protection of public health in the USA. The highest authority in the US for FDA approval is the Department of Health and Human Services, which governs and monitors the approval of laboratory equipment in the medical field. Time-consuming tests precede approval by the FDA. For the BINDER CB series this is the obligatory standard for all users in the field of human reproduction medicine. The CB series has the FDA approval.

The CB series can be all used for the cultivation of human ova and embryos. With very high demands made on the technical quality (tempering precision and control dynamics, highly accurate CO2/O2 regulation and a sterile culture environment) the CB incubator, listed as class 2 medical product, is approved for in-vitro fertilisation (IVF), intrauterine insemination (IUI) and human embryology. Consequently the CB incubator is clearly superior to other products, the rate of successful (IVF) applications increases significantly.

 

 
 
 
Co2 series
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Reference
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