FDA has jurisdiction over a range of products in i

FDA has jurisdiction over a range of products in interstate commerce including some devices and diagnostics-e.g, chapter 280 and 300's-

so maybe the company thought their products would come under 1 of those other headings-after all their jurisdictional boundaries have been the subject of a number of court cases
or one of the ingredients in the product -because if 1 of the ingredients of the diagnostics is subject to jurisdiction so is the final product

Compliance Policy Guides > CPG Sec. 100.200 FDA ...
http://www.fda.gov/ICECI/ComplianceManuals/CompliancePo...
Sep 17, 2009 ... 100.200 FDA Jurisdiction Over Products Composed of Interstate Ingredients ... This policy guide sets forth the position of FDA with respect to ...

at any rate I wasnt following it real close -and just accepted that they knew what they were doing -i otherwise had no interest in biotech- i was only in it because of the recommendation of a friend who was in it because of the good things the companies products would do- an ethical investor-

and only became mod as part of a collective effort by some of us to support the hangout as a viable alternative to the basher shorter sites who make money by targeting our stocks- sometimes in coordination w brokers and mm's- for vicious attacks -had to do something to jumpstart some of these boards

btw if either of you want to be added as asst mod let me know and i will do that so e.g. u can remove basher posts that violate tou