Rocky Mountain Diagnostics is in essence the US branch of the innovative biotech company Labor Diagnostika Nord GmbH & CO KG. We represent their full product line here in the USA and Canada. Together we are a truely global operation with a distributor and OEM network in over 80 countries. LDN was founded in 1996 in Nordhorn, Germany, with the aim to develop, manufacture and supply specialty in-vitro diagnostics test systems and innovative technologies to the clinical and research laboratory markets. From the beginning the determination of Biogenic Amines with immunological test systems was the core of our business, and still is today.
LDN has developed an extensive internal Quality Assurance program and their facilities are EN ISO 9001:2008 and EN ISO 13485:2003 + AC:2009 certified. LDN participates on a regular base in national (INSTAND) and international quality assessment programs.
All in-vitro diagnostics fulfil the regulations of the new European ivd directive (CE)