EDI is a
certified medical device manufacture company that focuses on niche immunoassays
for the global diagnostics and research industries specialize in ELISA kits,
rapid tests, and antibodies.
EDI has developed
and launched many innovative ELISA and rapid test kits that meet the needs of
healthcare communities worldwide. For instance, EDI launched the world's
first commercial test for the determination of alpha-1-HS-glycoprotein, the
human fetuin-A ELISA kit, In 2004, EDI was accredited by the Department
of Health Services, Food and Drug Branch in USA, as a certified and licensed
medical device manufacturer.
EDI developed and
innovative, odorless, and self-contained rapid test platform specifically for
stool sample-based rapid tests. This innovative device has been patented (US
7,780,915), FDA 510(k) cleared, and CLIA-waived since 2005, whereas this
platform has gone on to be the basis of all our rapid test kit, including the
European CE certified OTC kit, EpiTuub iFOB test.
Certificates: GMP-Certificate,
FDA Registration and CE Mark.