Company Profile
EraGen Biosciences
Molecular Diagnostics
Infectious Diseases
918 Deming Way, Ste 201
Madison, WI 53717-1944
USA
www.eragen.com
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Incorporated in 1999
43 Employees
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Privately Held
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This Year's Highlights
- EraGen successfully achieved ISO 13485/13488 certification, Quality System Requirements (QSR), Canadian Medical Device Requirements (CMDR) and In Vitro Diagnostic Device Directive (IVDD) compliance, and U.S. FDA establishment status.
- Launched 6 products into the clinical diagnostics market -- 3 ASRs (to detect HSV 1/2, Bordetella pertussis/parapertussis, and Enterovirus)and 3 RUO reagents (for JAK-2, Neisseria gonorrhoeae, and respiratory viruses.
- EraGen has achieved substantial customer traction with industry-leading molecular diagnostic laboratories, companies and research organizations. Secured product deals with two of the six national, tier-one clinical laboratories.
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Anticipated Highlights
- 510k clearance
- Launch additional ASR products.
- Expand customer base and increase revenues.
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Corporate Mission
EraGen BioSciences is a developer, manufacturer and marketer of next-generation molecular diagnostic genetic testing products for the early, accurate diagnosis of critical diseases.
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