US FDA Tags Theranos Sample Tubes As Uncleared Devices
This article was originally published in Clinica
Executive Summary
The US FDA has stated that the Nanotainer blood specimen collection tubes made by embattled laboratory firm Theranos were being sold without proper 510(k) clearance and also cited the firm for a range of Quality System Regulation deficiencies in two FDA Form-483s posted online Oct. 27.
You may also be interested in...
Theranos' Holmes, Balwani Slammed By SEC For 'Massive Fraud'
In another blow from the US government, securities regulators have severely penalized Theranos and its cofounder, Elizabeth Holmes, for allegedly lying to investors to raise funds.
Cosmetic And Personal Care Trademark Review: 16 April
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.
Health And Wellness Weekly Trademarks Review: 16 April
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.