Zybio Inc

FDA Filings

This page includes the latest FDA filings for Zybio 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: Marco Mu
• Owner & Operator: Zybio Inc.
• Official Correspondent:
  • Dan Qin
  • 86-023-68655509-x
• US Agent:
  • Marco Mu
  • MID-LINK INTERNATIONAL CO., LTD
  • 360 3257028
  • 360 9253199
  • us.agent@mid-link.net
• Registration Status: 5
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2219 Rimlang Drive, Suite 301 ; Bellingham, WA 98226 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
QKO Marco Mu [Zybio Inc.]	SARS-CoV-2 IgM/IgG Antibody Assay Kit (Colloidal Gold Method)	2020-04-15