Manufacturer and brand owner in Hangzhou, Zhejiang, China. 5 device types, 3 products catalogued, 1 clearance.
Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Reagent, Occult Blood, Container, Specimen, Sterile and 3 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
Registration
FDA registration record for Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. | Registered name | HANGZHOU GENESIS BIODETECTION & BIOCONTROL CO., LTD. |
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017231634 |
| FEI number | 3017231634 |
| DUNS | 547938709 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
Address of Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. | City | Hangzhou |
| Province | Zhejiang |
| Address | #139 10th Street (East) |
| Postal code | 310018 |
| Country | China |
From the Company
Published by the company on its own website, not by the FDA.
Information published by Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. | Founded | 2002 |
| Factory area | 51,000 m² |
| Main products | POCT rapid tests, Immunochromatography, Microbial detection, Biochemical turbidimetry, Home self-testing |
| Certifications | ISO 13485, ISO 9001, GMP |
| Export markets | 39 countries and regions |
| OEM and ODM | Offered |
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.