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.