Hangzhou Lysun Biotechnology Co., Ltd.
Registered establishment in Hangzhou, Zhejiang, China. 22 device types.
Hangzhou Lysun Biotechnology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Control, Fecal Occult Blood, Ldl & Vldl Precipitation, Hdl and 20 other device types. Its earliest product listing with the FDA dates from 2024.
Registration
| Registered name | HANGZHOU LYSUN BIOTECHNOLOGY CO.LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3021010433 |
| FEI number | 3021010433 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 杭州联晟生物科技有限公司 |
|---|---|
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | 6th Floor,6th Building, No. 95 Binwen Road, Xixin Street, Binjiang District |
| Postal code | 310053 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Acid, Uric, Uricase (Colorimetric) | Class 1 | Uric Acid Meter (GUM-102), Uric Acid Test Strip(Dry Chemistry)( UAS-101) | 2024 | 6 |
| Control, Fecal Occult Blood | Class 2 | Immunochemical Fecal Occult Blood Test Kit; Immunochemical Fecal Occult Blood (FOB) Test Kit, Immunochemical Fecal Occult Blood Test Kit | 2025 | 3 |
| Enzymatic Esterase–Oxidase, Cholesterol | Class 1 | Blood Lipid Test Strip (Dry Chemistry)(LPS-101), Blood Lipid Analysis System(LPM-101, LPM-102), Total Cholesterol Meter, Total Cholesterol Test Strip | 2024 | 9 |
| Kit, Identification, Mycobacteria | Class 1 | H. pylori Rapid Test Kit | 2025 | 2 |
| Ldl & Vldl Precipitation, Hdl | Class 1 | Blood Lipid Test Strip (Dry Chemistry)(LPS-101), High Density Lipoprotein Cholesterol Test Strip (Dry Chemistry)(HLS-101), Blood Lipid Analysis System(LPM-101, LPM- 102) | 2024 | 3 |
| Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | Class 1 | Blood Lipid Analysis System(LPM-101, LPM- 102), Blood Lipid Test Strip (Dry Chemistry)(LPS-101), Triglycerides Test Strip (Dry Chemistry)(TGS-101) | 2024 | 2 |
| Test System, Nicotine, Cotinine, Metabolites | Class 1 | Cotinine Rapid Test Strip ; Cotinine Rapid Test Cassette ; Cotinine Rapid Test Panel | 2024 | 11 |
| Test, Amphetamine, Employment And Insurance Testing, Exempt | Class 2 | Amphetamine Rapid Test Strip; Amphetamine Rapid Test Cassette; Amphetamine Rapid Test Panel, Multi-Drug Rapid Test (Urine) | 2024 | 11 |
| Test, Barbiturate, Employment And Insurance Testing, Exempt | Class 2 | Barbiturate Rapid Test Strip; Barbiturate Rapid Test Cassette; Barbiturate Rapid Test Panel | 2024 | 11 |
| Test, Benzodiazepine, Employment And Insurance Testing, Exempt | Class 2 | Benzodiazepine Rapid Test Strip; Benzodiazepine Rapid Test Cassette; Benzodiazepine Rapid Test Panel | 2024 | 11 |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | Class 2 | Cannabinoid Rapid Test Strip; Cannabinoid Rapid Test Cassette; Cannabinoid Rapid Test Panel, Marijuana (THC) Rapid Test (Urine); Marijuana (THC) Test Strips, Multi-Drug Rapid Test (Urine) | 2024 | 12 |
| Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt | Class 2 | Cocaine Rapid Test Strip ; Cocaine Rapid Test Cassette ; Cocaine Rapid Test Panel, Multi-Drug Rapid Test (Urine) | 2024 | 12 |
| Test, Codeine, Employment And Insurance Testing, Exempt | Class 2 | Codeine Rapid Test Strip; Codeine Rapid Test Cassette; Codeine Rapid Test Panel | 2024 | 4 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Class 1 | One Step FSH Test Strips (Urine), FOLLICLE STIMULATING HORMONE Rapid Test Strip; FOLLICLE STIMULATING HORMONE Rapid Test Cassette | 2024 | 30 |
| Test, Luteinizing Hormone (Lh), Over The Counter | Class 1 | Luteinizing Hormone Rapid Test Strip; Luteinizing Hormone Rapid Test Cassette | 2024 | 38 |
| Test, Methadone, Employment And Insurance Testing, Exempt | Class 2 | Methadone Rapid Test Strip; Methadone Rapid Test Cassette; Methadone Rapid Test Panel | 2024 | 11 |
| Test, Methamphetamine, Employment And Insurance Testing, Exempt | Class 2 | Methamphetamine Rapid Test Strip; Methamphetamine Rapid Test Cassette; Methamphetamine Rapid Test Panel, Multi-Drug Rapid Test (Urine) | 2024 | 13 |
| Test, Methaqualone, Employment And Insurance Testing, Exempt | Class 2 | Methaqualone Rapid Test Strip; Methaqualone Rapid Test Cassette; Methaqualone Rapid Test Panel | 2024 | 6 |
| Test, Morphine, Employment And Insurance Testing, Exempt | Class 2 | Morphine Rapid Test Strip; Morphine Rapid Test Cassette; Morphine Rapid Test Panel, Multi-Drug Rapid Test (Urine) | 2024 | 8 |
| Test, Opiates, Employment And Insurance Testing, Exempt | Class 2 | Opiates Rapid Test Strip; Opiates Rapid Test Cassette; Opiates Rapid Test Panel, Fentanyl (FYL) Rapid Test (Urine); Fentanyl (FYL) Test Strips, Fentanyl Rapid Test Strip; Fentanyl Rapid Test Cassette; Fentanyl Rapid Test Panel | 2024 | 12 |
| Test, Propoxyphene, Employment And Insurance Testing, Exempt | Class 2 | Propoxyphene Rapid Test Strip; Propoxyphene Rapid Test Cassette; Propoxyphene Rapid Test Panel | 2024 | 7 |
| Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt | Class 2 | Tricyclic antidepressant Rapid Test Strip; Tricyclic antidepressant Rapid Test Cassette, Tricyclic antidepressant Rapid Test Panel | 2024 | 7 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2018 |
|---|---|
| Main products | Blood Glucose Test, Lipid Test, Hemoglobin Test, Uric Acid Test, Renal Function Test |
| Certifications | EN ISO 13485:2016, EU CE |
| Export markets | International markets |
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.
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