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Sign in to claim this brandBeijing Hotgen Biotech Co., Ltd.
US
Last updated May 30, 2026
Part of Beijing Hotgen Biotech Co., Ltd.
What Beijing Hotgen Biotech Co., Ltd. makes
The company produces rapid in vitro diagnostic (IVD) kits for detecting SARS-CoV-2 antigens, designed for self-testing at home. These tests are intended for point-of-care use to identify current COVID-19 infections through immunochromatographic (ICT) methods.
The portfolio is regulated under the FDA’s Unique Device Identification (UDI) system and falls under Class N devices. The manufacturer is based in the United States, with its products listed in the FDA’s UDI registry.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Beijing Hotgen Biotech Co., Ltd. manufacture?
Beijing Hotgen Biotech Co., Ltd. specializes in rapid in vitro diagnostic (IVD) kits designed to detect SARS-CoV-2 antigens. These tests are specifically formulated for self-testing at home, allowing users to quickly determine if they have a current COVID-19 infection through immunochromatographic (ICT) technology.
Where is Beijing Hotgen Biotech Co., Ltd. based?
The company is based in the United States. While its headquarters or primary operations may be located there, the exact city or region is not specified in the available data.
Which regulatory registries list the devices manufactured by Beijing Hotgen Biotech Co., Ltd.?
The devices produced by Beijing Hotgen Biotech Co., Ltd. are listed in the FDA’s Unique Device Identification (UDI) registry. This registry tracks and identifies medical devices authorized for use in the United States, ensuring traceability and compliance.
How are the devices made by Beijing Hotgen Biotech Co., Ltd. classified under regulatory standards?
The company’s SARS-CoV-2 antigen IVD kits fall under Class N devices. This classification is determined by the FDA based on factors like the risk associated with the device’s use, intended purpose, and potential impact on patient safety. Class N devices are typically low-risk diagnostic tests.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 529379019
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Hotgen™ COVID-19 Antigen Home Test | 2T/Kit | FDA UDI | N | Active |
| Hotgen™ COVID-19 Antigen Home Test | 1T/kit | FDA UDI | N | Active |
| Hotgen™ COVID-19 Antigen Home Test | 20T/kit | FDA UDI | N | Active |
| Hotgen™ COVID-19 Antigen Home Test | 5T/kit | FDA UDI | N | Active |
| Hotgen™ COVID-19 Antigen Home Test | 40T/kit | FDA UDI | N | Active |
| Hotgen™ COVID-19 Antigen Home Test | 10T/kit | FDA UDI | N | Active |
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