Going back to the test, if you did go over their website it seems that the WHO approved of this test, I live in the Philippines and I don't think the approved US test kit is available here, any comments? If WHO can approve this test is it possible that it has undergone qualitative testing?
Another warning letter.
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/ucm213005.htm
Here is an FDA warning. They are unapproved in the US.
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/ucm210825.htm