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 Number: 3009414546
• FEI Number: 3009414546
• Name: HANGZHOU CLONGENE BIOTECH CO., LTD.
• Owner & Operator: Hangzhou Clongene Biotech Co., Ltd.
• Contact Address: No.1 Yichuang Road Yuhang District; Hangzhou CN-33 Zhejiang 311121 CN
• Official Correspondent:
  • Shujian Zheng
  • 86-571-88262120-x
• US Agent:
  • Jesse Xia
  • LSI International Inc
  • 240 5057880
  • jxia@lsi-consulting.org
• Importing Logistics Registration:
  • Importer: ProVen Pharmaceuticals
  • Address: 4110 Butler Pike, Suite A 101D ; Plymouth Meeting, PA 19462 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: No.1 Yichuang Road Yuhang District; Hangzhou Zhejiang, 311121 CN
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 06950921302377 Hangzhou Clongene Biotech Co., Ltd.	CLUNGENE	2023-09-18
QKO HANGZHOU CLONGENE BIOTECH CO., LTD.	Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette	2020-04-01
PMN K193132 | LCX HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE HCG Pregnancy Rapid Test Strip	2020-01-10
PMN K193132 | LCX HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE HCG Pregnancy Rapid Test Midstream	2020-01-10
PMN K193132 | LCX HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE HCG Pregnancy Rapid Test Cassette	2020-01-10
PMN K193132 Hangzhou Clongene Biotech Co.,Ltd.	CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream	2019-12-11
PMN K190412 | QBF HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Multi-Drug Test Easy Cup	2019-04-04
PMN K190412 | QBF HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Multi-Drug Test Dip Card	2019-04-04
PMN K190412 | PTG HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Multi-Drug Test Easy Cup	2019-04-04
PMN K190412 | PTG HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Multi-Drug Test Dip Card	2019-04-04
PMN K190412 | NGL HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Multi-Drug Test Easy Cup	2019-04-04
PMN K190412 | NGL HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Multi-Drug Test Dip Card	2019-04-04
PMN K190412 Hangzhou Clongene Biotech Co.,Ltd.	CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup	2019-03-21
PMN K181790 | QAW HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Dip Card	2018-11-02
PMN K181790 | QAW HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Cup	2018-11-02
PMN K181790 | NGM HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Dip Card	2018-11-02
PMN K181790 | NGM HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Cup	2018-11-02
PMN K181790 | NGL HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Dip Card	2018-11-02
PMN K181790 | NGL HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Cup	2018-11-02
PMN K181790 | NGG HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Dip Card	2018-11-02
PMN K181790 | NGG HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Cup	2018-11-02
PMN K180255 | PTH HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Dip Card	2018-11-02
PMN K180255 | PTH HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Cup	2018-11-02
PMN K180255 | PTG HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Dip Card	2018-11-02
PMN K180255 | PTG HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Cup	2018-11-02
PMN K180255 | NGL HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Dip Card	2018-11-02
PMN K180255 | NGL HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Cup	2018-11-02
PMN K180255 | NGG HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Dip Card	2018-11-02
PMN K180255 | NGG HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Cup	2018-11-02
PMN K180255 | NFY HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Dip Card	2018-11-02
PMN K180255 | NFY HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Cup	2018-11-02
PMN K180255 | NFW HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Dip Card	2018-11-02
PMN K180255 | NFW HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Cup	2018-11-02
PMN K180255 | NFV HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Dip Card	2018-11-02
PMN K180255 | NFV HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Cup	2018-11-02
PMN K180255 | NFT HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Dip Card	2018-11-02
PMN K180255 | NFT HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE? Multi-Drug Test Cup	2018-11-02
PMN K181790 Hangzhou Clongene Biotech Co.,Ltd.	CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup	2018-07-26
PMN K180255 Hangzhou Clongene Biotech Co.,Ltd.	CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup	2018-02-28
NGE HANGZHOU CLONGENE BIOTECH CO., LTD.	Clungene LH Ovulation Rapid Test Strip	2017-11-30
NGE HANGZHOU CLONGENE BIOTECH CO., LTD.	Clungene LH Ovulation Rapid Test Midstream	2017-11-30
NGE HANGZHOU CLONGENE BIOTECH CO., LTD.	Clungene LH Ovulation Rapid Test Cassette	2017-11-30
PMN K161251 | JXM HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Oxazepam Tests	2016-11-09
PMN K161251 | JXM HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Cocaine Tests	2016-11-09
PMN K161251 | JXM HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Amphetamine Tests	2016-11-09
PMN K161251 | DKZ HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Oxazepam Tests	2016-11-09
PMN K161251 | DKZ HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Cocaine Tests	2016-11-09
PMN K161251 | DKZ HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Amphetamine Tests	2016-11-09
PMN K161251 | DIO HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Oxazepam Tests	2016-11-09
PMN K161251 | DIO HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Cocaine Tests	2016-11-09
PMN K161251 | DIO HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Amphetamine Tests	2016-11-09
PMN K161251 Hangzhou Clongene Biotech Co., Ltd	CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests	2016-08-30
PMN K153741 | LDJ HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Drug Tests Dip Card	2016-04-12
PMN K153741 | LDJ HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Drug Tests Cup	2016-04-12
PMN K153741 | LDJ HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Drug Tests Cassette	2016-04-12
PMN K153741 | DJG HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Drug Tests Dip Card	2016-04-12
PMN K153741 | DJG HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Drug Tests Cup	2016-04-12
PMN K153741 | DJG HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Drug Tests Cassette	2016-04-12
PMN K153741 | DJC HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Drug Tests Dip Card	2016-04-12
PMN K153741 | DJC HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Drug Tests Cup	2016-04-12
PMN K153741 | DJC HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Drug Tests Cassette	2016-04-12
PMN K153741 HANGZHOU CLONGENE BIOTECH CO., LTD.	CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test	2016-03-18

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019082125860	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	DIAGNOSTIC KIT	44 CTN