Hangzhou Clongene Biotech Co., Ltd.
Manufacturer and brand owner in Hangzhou, Zhejiang, China. 21 device types, 6 products catalogued, 9 clearances.
Hangzhou Clongene Biotech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Enzyme Immunoassay, Opiates, Enzyme Immunoassay, Amphetamine and 19 other device types. 6 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2016.
21device types registered with the FDA
6products catalogued under its own name
9510(k) clearances
Registration
| Registered name | HANGZHOU CLONGENE BIOTECH CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009414546 |
| FEI number | 3009414546 |
| DUNS | 724157438 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 杭州隆基生物技术有限公司 |
|---|---|
| Unified social credit code | 913301107620252127 |
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | No.1 Yichuang Road, Yuhang Sub-district |
| Postal code | 311121 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | Class 1 | Clungene RSV Antigen Rapid Test | 2026 | 4 |
| Enzyme Immunoassay, Amphetamine | Class 2 | CLUNGENE Oxazepam Tests, CLUNGENE Cocaine Tests, CLUNGENE Amphetamine Tests | 2016 | 16 |
| Enzyme Immunoassay, Benzodiazepine | Class 2 | CLUNGENE Oxazepam Tests, CLUNGENE Cocaine Tests, CLUNGENE Amphetamine Tests | 2016 | 13 |
| Enzyme Immunoassay, Cannabinoids | Class 2 | CLUNGENE Drug Tests Cassette, CLUNGENE Drug Tests Dip Card, CLUNGENE Drug Tests Cup | 2016 | 18 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Class 2 | CLUNGENE Oxazepam Tests, CLUNGENE Cocaine Tests, CLUNGENE Amphetamine Tests | 2016 | 16 |
| Enzyme Immunoassay, Opiates | Class 2 | CLUNGENE Drug Tests Cassette, CLUNGENE Drug Tests Dip Card, CLUNGENE Drug Tests Cup | 2016 | 17 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | Class 2 | CLUNGENE HCG Pregnancy Rapid Test Midstream, CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip | 2020 | 30 |
| Test, Amphetamine, Over The Counter | Class 2 | CLUNGENE Multi-Drug Home Test Easy Cup, CLUNGENE Multi-Drug Test Easy Cup, CLUNGENE® Multi-Drug Test Cup, CLUNGENE® Multi-Drug Test Dip Card | 2018 | 16 |
| Test, Barbiturate, Over The Counter | Class 2 | CLUNGENE Multi-Drug Home Test Easy Cup, CLUNGENE Multi-Drug Test Easy Cup, CLUNGENE® Multi-Drug Test Cup, CLUNGENE® Multi-Drug Test Dip Card | 2018 | 16 |
| Test, Benzodiazepine, Over The Counter | Class 2 | CLUNGENE Multi-Drug Home Test Easy Cup, CLUNGENE Multi-Drug Test Easy Cup, CLUNGENE® Multi-Drug Test Cup, CLUNGENE® Multi-Drug Test Dip Card | 2018 | 16 |
| Test, Cannabinoid, Over The Counter | Class 2 | CLUNGENE Multi-Drug Home Test Easy Cup, CLUNGENE Multi-Drug Test Easy Cup, CLUNGENE® Multi-Drug Test Cup, CLUNGENE® Multi-Drug Test Dip Card | 2018 | 16 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | Class 2 | CLUNGENE Multi-Drug Home Test Easy Cup, CLUNGENE Multi-Drug Test Easy Cup, CLUNGENE® Multi-Drug Test Cup, CLUNGENE® Multi-Drug Test Dip Card | 2018 | 16 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Class 1 | CLUNGENE® FSH Menopause Rapid Test Midstream, CLUNGENE® FSH Menopause Rapid Test Cassette, CLUNGENE® FSH Menopause Rapid Test Strip | 2020 | 30 |
| Test, Luteinizing Hormone (Lh), Over The Counter | Class 1 | Clungene LH Ovulation Rapid Test Strip, Clungene LH Ovulation Rapid Test Cassette, Clungene LH Ovulation Rapid Test Midstream | 2017 | 38 |
| Test, Methadone, Over The Counter | Class 2 | CLUNGENE Multi-Drug Home Test Easy Cup, CLUNGENE Multi-Drug Test Easy Cup, CLUNGENE® Multi-Drug Test Cup, CLUNGENE® Multi-Drug Test Dip Card | 2018 | 17 |
| Test, Methamphetamine, Over The Counter | Class 2 | CLUNGENE Multi-Drug Home Test Easy Cup, CLUNGENE Multi-Drug Test Easy Cup, CLUNGENE® Multi-Drug Test Cup, CLUNGENE® Multi-Drug Test Dip Card | 2018 | 16 |
| Test, Opiates, Over The Counter | Class 2 | CLUNGENE Multi-Drug Home Test Easy Cup, CLUNGENE Multi-Drug Test Easy Cup, CLUNGENE Fentanyl Test Cassette, CLUNGENE Fentanyl Home Test Cassette, CLUNGENE® Multi-Drug Test Cup, CLUNGENE® Multi-Drug Test Dip Card | 2018 | 18 |
| Test, Phencyclidine (Pcp), Over The Counter | Class U | CLUNGENE Multi-Drug Home Test Easy Cup, CLUNGENE Multi-Drug Test Easy Cup, CLUNGENE® Multi-Drug Test Cup, CLUNGENE® Multi-Drug Test Dip Card | 2018 | 12 |
| Test, Propoxyphene, Over The Counter | Class 2 | CLUNGENE Multi-Drug Home Test Easy Cup, CLUNGENE Multi-Drug Test Easy Cup | 2026 | 16 |
| Test, Tricyclic Antidepressants, Over The Counter | Class 2 | CLUNGENE Multi-Drug Home Test Easy Cup, CLUNGENE Multi-Drug Test Easy Cup, CLUNGENE® Multi-Drug Test Cup, CLUNGENE® Multi-Drug Test Dip Card | 2018 | 16 |
| Thin Layer Chromatography, Methamphetamine | Class 2 | CLUNGENE Drug Tests Cassette, CLUNGENE Drug Tests Dip Card, CLUNGENE Drug Tests Cup | 2016 | 12 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253318 | 2026-01-30 | GQG | Traditional | This company |
| K252118 | 2025-08-27 | NFT | Traditional | This company |
| K242802 | 2024-11-08 | NGL | Traditional | This company |
| K193132 | 2019-12-11 | LCX | Traditional | This company |
| K190412 | 2019-03-21 | NGL | Traditional | This company |
| K181790 | 2018-07-26 | NGL | Traditional | This company |
| K180255 | 2018-02-28 | PTH | Traditional | This company |
| K161251 | 2016-08-30 | DKZ | Traditional | This company |
| K153741 | 2016-03-18 | LDJ | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2004 |
|---|---|
| Factory area | 34000 sq m |
| Main products | COVID-19 antigen detection kits, Dengue virus NS1 antigen detection kits, HIV antibody detection kits, multi-drug combination detection kits, cardiac biomarker detection kits |
| Certifications | NMPA, FDA, CE |
| Export markets | 100+ countries |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.