Maccura Biotechnology Co L T D

FDA Filings

This page includes the latest FDA filings for Maccura Biotechnology Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

CHINA

SHENZHEN STOCK EXCHANGE

300463

DUNS 529054231

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