Ansh Labs obtains CE Marks for picoAMH, Inhibin A and picoPAPP-A Assays

Ansh Labs obtains CE Marks for picoAMH, Inhibin A and picoPAPP-A Assays

Ansh Labs has obtained CE marking for several of its immunodiagnostic products.  After successfully completing its ISO 13485 and ISO 9001 certification, the company filed for CE marking through its European Authorized Representative, RD-RatioDiagnostics GmbH (Frankfurt, Germany).

The following assays have met the provisions of the European Directive 98/79/EC for in vitro diagnostic medical devices:

• picoAMH ELISA*
• picoPAPP-A ELISA*
• Inhibin A ELISA*
• AnshLite™ picoPAPP-A CLIA*
• AnshLite™ Inhibin A CLIA*

*The CE-marked products are for export only and not for sale in the United States.

These products join the Ansh Labs expanding menu of assays that have previously met the provisions of the European Directive 98/79/EC for in vitro diagnostic medical devices.