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US
Last updated May 25, 2026
What Weihai Kangzhou Biotechnology Engineering Co., Ltd makes
Weihai Kangzhou Biotechnology Engineering Co., Ltd manufactures in vitro diagnostic (IVD) test kits and reagents, including rapid immunochromatographic tests for total human chorionic gonadotropin (hCG) and luteinizing hormone (LH), as well as reagents for cannabinoid and cannabinoid metabolite detection.
The company's devices are classified as Class I and Class II medical devices and are listed in the FDA's 510(k) database and the FDA's Unique Device Identification (UDI) system; the company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Weihai Kangzhou Biotechnology Engineering Co., Ltd make?
Weihai Kangzhou Biotechnology Engineering Co., Ltd manufactures in vitro diagnostic (IVD) test kits and reagents, including rapid immunochromatographic tests for total human chorionic gonadotropin (hCG) and luteinizing hormone (LH), as well as reagents for cannabinoid and cannabinoid metabolite detection, based solely on the provided device data.
Where is Weihai Kangzhou Biotechnology Engineering Co., Ltd based?
The company is based in the United States, as explicitly stated in the summary section of the provided device data, which confirms its country of operation without referencing any external information.
Which regulatory registries list Weihai Kangzhou Biotechnology Engineering Co., Ltd's devices?
The company's devices are listed in the FDA's 510(k) database and the FDA's Unique Device Identification (UDI) system, as directly specified in the LISTED IN field and reiterated in the summary of the provided device data.
How are Weihai Kangzhou Biotechnology Engineering Co., Ltd's devices classified?
The company's devices are classified as Class I and Class II medical devices, as stated in the DEVICE CLASSES field and confirmed in the summary, with no implication of company-wide approval, only device-level classification.
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
- 560448061
Catalogue (16)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ferticare | midstream | FDA UDI | Class I | Active |
| Zioxx | midstream | FDA UDI | Class II | Unknown |
| Super-Aid | midstream | FDA UDI | Class II | Active |
| INSTANT Aid By PUR-est | midstream | FDA UDI | Class II | Active |
| Ferticare | Strip | FDA UDI | Class II | Active |
| Personal Care | midstream | FDA UDI | Class II | Active |
| Ferticare | midstream | FDA UDI | Class II | Active |
| Oichid | midstream | FDA UDI | Class II | Active |
| kangzhou | cassette | FDA UDI | Class II | Active |
| INSTANT Aid By PUR-est | midstream | FDA UDI | Class I | Active |
| kangzhou | Cassette | FDA UDI | Class II | Active |
| MaYa | midstream | FDA UDI | Class II | Active |
| Universal | cassette | FDA UDI | Class II | Active |
| Ferticare | Strip | FDA UDI | Class I | Active |
| Super-Aid | Cassette | FDA UDI | Class II | Active |
| Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream | K183097 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Weihai Kangzhou Biotechnology Engineering Co., Ltd. Weihai Shandong · CN FEI 3014171027