Cholestech LDX^® System - classified as CLIA-waived by the FDA. That means that you'll need to get a CLIA Certificate of Waiver before you begin testing*. Getting a waiver is a simple process, so whether you need to get certified or stay certified here's what you need to get going.

3 Easy Steps to Obtaining and Maintaining a CLIA Certificate of Waiver**

• Get Certified: Apply for CLIA Certificate of Waiver
  Download a CLIA application form (CMS-116)
  Follow the instructions provided, then send it to the appropriate state agency.
  View Contact Numbers
• Stay certified: Double check
  CLIA requirements for each state are different. Contact a CLIA office in your state to learn about specific requirements
• Stay organized: Keep required documentation
  Print out and keep a binder with the following materials that are required by CLIA. All the documents you need are here, and they are also available on your starter kit CD Procedure Manual.

LDX System:
• User Manual
• Procedure Manual

• Result logs
• Quality Control logs
• Material Safety Data Sheets
• Optics Check log
• View the training video and complete the corresponding certification quiz to receive a certificate of training

Useful links for Accreditation Organizations:

Independent accreditation organizations
[ pdf | 10k ]
Joint Commission
Joint Commission on Accreditation of Healthcare Organizations
CAP
College of American Pathologists

*All tests that run with LDX Systems with the exception of hs-CRP require CLIA waiver. hs-CRP testing requires certification for nonwaived tests, contact your CLIA office to learn more about nonwaived testing.

**CLIA requirements for physician offices, pharmacies and hospitals differ. Contact your state CLIA office to learn about CLIA requirements for your health organization.

These links are provided for general educational purposes only. They are not endorsed or authorized by Inverness Medical.