Zhuhai Livzon Diagnostics Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 0
• FEI Number: 0
• Name: Scott L. Hopes
• Owner & Operator: Zhuhai Livzon Diagnostics Inc.
• Official Correspondent:
  • Junying Dai
  • 86-756-8919728-x
• US Agent:
  • Scott L. Hopes
  • CliniLinc Diagnostics, LLC
  • 941 2272688
  • shopes@clinilinc.com
• Importing Logistics Registration:
  • Importer: CliniLinc Diagnostics LLC
  • Address: 120 South Monroe Street ; Tallahassee, FL 32301 UNITED STATES
  • Email Address: SHopes@CliniLinc.com
  • Phone: 1 941 2272688
  • Importer Type: Agent
• Registration Status: 5
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 326 Montgomery AVE ; Sarasota, FL 34243 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
QKO Scott L. Hopes [Zhuhai Livzon Diagnostics Inc.]	Livzon CliniLinc Diagnostic Kit for IgM/IgG Antibody to Coronavirus SARS-CoV-2 (Lateral Flow)	2020-04-14