Dynamiker Biotechnology Tianjin Co L T D

FDA Filings

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

FDA Registration(s)

• Registration Number: 3012452932
• FEI Number: 3012452932
• Name: DYNAMIKER BIOTECHNOLOGY (TIANJIN) CO., LTD.
• Owner & Operator: Dynamiker Biotechnology (Tianjin) Co., Ltd.
• Contact Address: No. 14 Building, Eco-Business Park, 2018 ; Tianjin CN-12 Tianjin 300467 CN
• Official Correspondent:
  • Yuqing Cao
  • 86-022-60101551-x
• US Agent:
  • Marco Mu
  • MID-LINK INTERNATIONAL CO., LTD
  • 360 3257028
  • 360 9253199
  • us.agent@mid-link.net
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: No. 14 Building, Eco-Business Park, 2018 Zhongtian Avenue, Sino- ; Tianjin Tianjin, 300467 CN
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
MDU DYNAMIKER BIOTECHNOLOGY (TIANJIN) CO., LTD.	Dynamiker Cryptococcal Antigen Lateral Flow Assay(LFA)	2019-06-02
LSG DYNAMIKER BIOTECHNOLOGY (TIANJIN) CO., LTD.	Dynamiker Candida albicans IgG Assay	2019-06-02
LSG DYNAMIKER BIOTECHNOLOGY (TIANJIN) CO., LTD.	Dynamiker Candida Mannan Assay	2019-06-02
LSG DYNAMIKER BIOTECHNOLOGY (TIANJIN) CO., LTD.	Dynamiker Candida IgG Lateral Flow Assay(LFA)	2019-06-02
JWT DYNAMIKER BIOTECHNOLOGY (TIANJIN) CO., LTD.	QuicIgG^TM Aspergillus IgG Ab Lateral Flow Assay	2019-06-02
JWT DYNAMIKER BIOTECHNOLOGY (TIANJIN) CO., LTD.	Dynamiker Aspergillus fumigatus IgG Assay	2019-06-02