Hangzhou Biotest Biotech Co L T D

FDA Filings

This page includes the latest FDA filings for Hangzhou Biotest Biotech 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 Number3011522054
FEI Number3011522054
NameXiaoxi Wang
Owner & OperatorHangzhou Biotest Biotech Co.,Ltd.
Contact Address17#,Futai Road,Zhongtai Street,Yuhang
Hangzhou CN-33 Zhejiang 311121 CN
Official Correspondent
  • WADE WU
  • 86-571-89058168-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address10340 CAMINO SANTA FE STE G
San Diego, CA 92121 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Xiaoxi Wang [Hangzhou Biotest Biotech Co.,Ltd.]
RightSign? COVID-19 IgG/IgM Rapid Test Cassette(Whole Blood/ Plasma/Serum)2020-03-20
Xiaoxi Wang [Hangzhou Biotest Biotech Co.,Ltd.]
Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette(Whole Blood/ Plasma/Serum)2020-03-20
Xiaoxi Wang [Hangzhou Biotest Biotech Co.,Ltd.]
Ovios COVID-19 IgG/IgM Rapid Test Cassette(Whole Blood/ Plasma/Serum)2020-03-20
Xiaoxi Wang [Hangzhou Biotest Biotech Co.,Ltd.]
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/ Plasma/Serum)2020-03-20
Xiaoxi Wang [Hangzhou Biotest Biotech Co.,Ltd.]
CORONACHEK COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/ Plasma/Serum)2020-03-20
Xiaoxi Wang [Hangzhou Biotest Biotech Co.,Ltd.]
Rightsign Ms.Tellme2015-10-26
Xiaoxi Wang [Hangzhou Biotest Biotech Co.,Ltd.]
Advin Multi-Drug Screen Test2015-06-05
Xiaoxi Wang [Hangzhou Biotest Biotech Co.,Ltd.]
Advin Multi-Drug Screen Test2015-06-05
Xiaoxi Wang [Hangzhou Biotest Biotech Co.,Ltd.]
Advin Multi-Drug Screen Test2015-06-05
Xiaoxi Wang [Hangzhou Biotest Biotech Co.,Ltd.]
Advin Multi-Drug Screen Test2015-06-05
Xiaoxi Wang [Hangzhou Biotest Biotech Co.,Ltd.]
Advin Multi-Drug Screen Test2015-06-05
Xiaoxi Wang [Hangzhou Biotest Biotech Co.,Ltd.]
Advin Multi-Drug Screen Test2015-06-05
Xiaoxi Wang [Hangzhou Biotest Biotech Co.,Ltd.]
Advin Multi-Drug Screen Test2015-06-05
Xiaoxi Wang [Hangzhou Biotest Biotech Co.,Ltd.]
Advin Multi-Drug Screen Test2015-06-05
Xiaoxi Wang [Hangzhou Biotest Biotech Co.,Ltd.]
Advin Multi-Drug Screen Test2015-06-05
Xiaoxi Wang [Hangzhou Biotest Biotech Co.,Ltd.]
Advin Multi-Drug Screen Test2015-06-05
Xiaoxi Wang [Hangzhou Biotest Biotech Co.,Ltd.]
Advin Multi-Drug Screen Test2015-06-05

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092154147Shanghai ,China (Mainland) -> Long Beach, CaliforniaDIAGNOSTIC TESTS750 PKG
2020092154147Shanghai ,China (Mainland) -> Long Beach, CaliforniaDIAGNOSTIC TESTS750 PKG
2020090983901Shanghai ,China (Mainland) -> Long Beach, CaliforniaDIAGNOSTIC TESTS475 CTN
2020082559271Shanghai ,China (Mainland) -> Long Beach, CaliforniaDIAGNOSTIC TEST, MOS PREGNANCY OVULATION POUC H17 CTN
2020082446581Shanghai ,China (Mainland) -> Long Beach, CaliforniaCHEMCIALS, NON-HAZARDOUS NOS DIAGNOSTIC TESTS193 CTN
2020081866641Shanghai ,China (Mainland) -> Long Beach, CaliforniaCHEMCIALS, NON-HAZARDOUS NOS DIAGNOSTIC TESTS193 CTN
2020080556251Shanghai ,China (Mainland) -> Long Beach, CaliforniaDIAGNOSTIC TESTS688 CTN
2020080556251Shanghai ,China (Mainland) -> Long Beach, CaliforniaDIAGNOSTIC TESTS688 CTN
2020072760722Shanghai ,China (Mainland) -> Long Beach, CaliforniaDIAGNOSTIC TESTS,CUP BODY,CUP CAP477 CTN
2020072160050Shanghai ,China (Mainland) -> Long Beach, CaliforniaDIAGNOSTIC TESTS,CUP BODY,CUP CAP477 CTN

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