Hangzhou Clongene Biotech Co., Ltd.

Manufacturer

🇨🇳 China·7 Basic UDI-DIs·7 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

CLUNGENE Drug Tests Cup

FDA registration

HANGZHOU CLONGENE BIOTECH CO., LTD.·3 products·🇨🇳 China

CLUNGENE HCG Pregnancy Rapid Test Strip

FDA registration

HANGZHOU CLONGENE BIOTECH CO., LTD.·1 product·🇨🇳 China

Clungene LH Ovulation Rapid Test Cassette

FDA registration

HANGZHOU CLONGENE BIOTECH CO., LTD.·1 product·🇨🇳 China

CLUNGENE Oxazepam Tests

FDA registration

HANGZHOU CLONGENE BIOTECH CO., LTD.·3 products·🇨🇳 China

CLUNGENE® FSH Menopause Rapid Test Midstream

FDA registration

HANGZHOU CLONGENE BIOTECH CO., LTD.·1 product·🇨🇳 China

CLUNGENE® Multi-Drug Test Dip Card

FDA registration

HANGZHOU CLONGENE BIOTECH CO., LTD.·8 products·🇨🇳 China

CLUNGENE Fentanyl Test Cassette

FDA registration

HANGZHOU CLONGENE BIOTECH CO., LTD.·1 product·🇨🇳 China

CLUNGENE® Multi-Drug Test Cup

FDA registration

HANGZHOU CLONGENE BIOTECH CO., LTD.·4 products·🇨🇳 China

CLUNGENE

FDA UDI

Hangzhou Clongene Biotech Co., Ltd.·06950921302377·

Fecal Occult Blood Rapid Test

Device

EU IVDD · Eu Ivd General ·Hangzhou Clongene Biotech Co., Ltd.·On the market

H.pylori Antigen Rapid Test Cassette (Feces)

Device

EU IVDD · Eu Ivd General ·Hangzhou Clongene Biotech Co., Ltd.·On the market

Marijuana (THC) Rapid Test

Device

EU IVDD · Eu Ivd General ·Hangzhou Clongene Biotech Co., Ltd.·On the market

COVID-19 Antigen Rapid Test

Device

EU IVDD · Eu Ivd General ·Hangzhou Clongene Biotech Co., Ltd.·On the market

LH Ovulation Rapid Tests

Device

EU IVDD · Eu Ivd Self Testing ·Hangzhou Clongene Biotech Co., Ltd.·On the market

HCG Pregnancy Rapid Tests

Device

EU IVDD · Eu Ivd Self Testing ·Hangzhou Clongene Biotech Co., Ltd.·On the market

COVID-19 Antigen Rapid Test

Device

EU IVDD · Eu Ivd Self Testing ·Hangzhou Clongene Biotech Co., Ltd.·On the market·1 country

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test

FDA 510(k)

FDA Class 2 ·Clinical Toxicology