Hangzhou Clongene Biotech Co L T D

FDA Filings

This page includes the latest FDA filings for Hangzhou Clongene 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 Number3009414546
FEI Number3009414546
NameHANGZHOU CLONGENE BIOTECH CO., LTD.
Owner & OperatorHangzhou Clongene Biotech Co., Ltd.
Contact AddressNo.1 Yichuang Road Yuhang District
Hangzhou CN-33 Zhejiang 311121 CN
Official Correspondent
  • Shujian Zheng
  • 86-571-88262120-x
US Agent
Importing Logistics Registration
ImporterProVen Pharmaceuticals
Address4110 Butler Pike, Suite A 101D
Plymouth Meeting, PA 19462 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressNo.1 Yichuang Road Yuhang District
Hangzhou Zhejiang, 311121 CN
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
HANGZHOU CLONGENE BIOTECH CO., LTD.
Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette2020-04-01
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE HCG Pregnancy Rapid Test Strip2020-01-10
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE HCG Pregnancy Rapid Test Midstream2020-01-10
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE HCG Pregnancy Rapid Test Cassette2020-01-10
Hangzhou Clongene Biotech Co.,Ltd.
CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream2019-12-11
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Multi-Drug Test Easy Cup2019-04-04
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Multi-Drug Test Dip Card2019-04-04
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Multi-Drug Test Easy Cup2019-04-04
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Multi-Drug Test Dip Card2019-04-04
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Multi-Drug Test Easy Cup2019-04-04
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Multi-Drug Test Dip Card2019-04-04
Hangzhou Clongene Biotech Co.,Ltd.
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup2019-03-21
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Dip Card2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Cup2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Dip Card2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Cup2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Dip Card2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Cup2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Dip Card2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Cup2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Dip Card2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Cup2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Dip Card2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Cup2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Dip Card2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Cup2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Dip Card2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Cup2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Dip Card2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Cup2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Dip Card2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Cup2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Dip Card2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Cup2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Dip Card2018-11-02
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE? Multi-Drug Test Cup2018-11-02
Hangzhou Clongene Biotech Co.,Ltd.
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup2018-07-26
Hangzhou Clongene Biotech Co.,Ltd.
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup2018-02-28
HANGZHOU CLONGENE BIOTECH CO., LTD.
Clungene LH Ovulation Rapid Test Strip2017-11-30
HANGZHOU CLONGENE BIOTECH CO., LTD.
Clungene LH Ovulation Rapid Test Midstream2017-11-30
HANGZHOU CLONGENE BIOTECH CO., LTD.
Clungene LH Ovulation Rapid Test Cassette2017-11-30
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Oxazepam Tests2016-11-09
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Cocaine Tests2016-11-09
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Amphetamine Tests2016-11-09
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Oxazepam Tests2016-11-09
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Cocaine Tests2016-11-09
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Amphetamine Tests2016-11-09
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Oxazepam Tests2016-11-09
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Cocaine Tests2016-11-09
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Amphetamine Tests2016-11-09
Hangzhou Clongene Biotech Co., Ltd
CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests2016-08-30
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Drug Tests Dip Card2016-04-12
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Drug Tests Cup2016-04-12
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Drug Tests Cassette2016-04-12
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Drug Tests Dip Card2016-04-12
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Drug Tests Cup2016-04-12
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Drug Tests Cassette2016-04-12
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Drug Tests Dip Card2016-04-12
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Drug Tests Cup2016-04-12
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Drug Tests Cassette2016-04-12
HANGZHOU CLONGENE BIOTECH CO., LTD.
CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test2016-03-18

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2019082125860Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New JerseyDIAGNOSTIC KIT44 CTN

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.