Renlin Li

FDA Filings

This page includes the latest FDA filings for Renlin Li. 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: Renlin Li
• Owner & Operator: Maccura Biotechnology Co., Ltd.
• Official Correspondent:
  • Renlin Li
  • 86-28-87826777-x
• US Agent:
  • Renlin Li
  • 240 6699984
  • renlinli@ext.maccura.com
• Registration Status: 5
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 11300 Rockville Pike, Suite 715, Rockville ; Rockville, MD 20852 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
QKO Renlin Li [Maccura Biotechnology Co., Ltd.]	Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method	2020-04-15
QJR Renlin Li [Maccura Biotechnology Co., Ltd.]	SARS-CoV-2 Fluorescent PCR Kit	2020-04-15