Cellex

FDA Filings

This page includes the latest FDA filings for Cellex. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3014277758
• FEI Number: 3014277758
• Name: CELLEX
• Owner & Operator: CELLEX
• Contact Address: 76 TW Alexander Drive PO Box 12808; Research Triangle Park NC 27709 US
• Official Correspondent:
  • X. James Li
  • x-919-3145535-1607
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 76 TW Alexander Drive ; Research Triangle Park, NC 27709 US
• Establishment Type:
  • Manufacture Device in the United States for Export Only
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
QKO CELLEX	qSARS-CoV-2 IgG/IgM Rapid Test	2020-04-19
LIB CELLEX	CELLEX, INCORPORATED	2018-02-09