FDA Registration
Active
🇨🇳 China
HANGZHOU LYSUN BIOTECHNOLOGY CO.LTD
Reg #: 3021010433
·
FEI: 3021010433
·
Expires 2026
Products
22
Proprietary Names
34
Establishment Types
1
Classifications
22
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Registration Details
- Registration Name
- HANGZHOU LYSUN BIOTECHNOLOGY CO.LTD
- Registration Number
- 3021010433
- FEI Number
- 3021010433
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6th Floor,6th Building, No. 95 Binwen Road, Xixin Street, Binjiang District
- City
- Hangzhou Zhejiang
- Country
- CN
Owner / Operator
- Firm Name
- HANGZHOU LYSUN BIOTECHNOLOGY CO.LTD
- Operator Number
- 10089876
- Address
- 6th Floor,6th Building, No. 95 Binwen Road, Xixin Street, Binjiang District
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 310053
- Country
- CN
- Correspondent
- Jake Chen
US Agent
- Business Name
- GRZAN GROUP INC.
- Contact Name
- Andy Smith
- Address
- 8825 53 AVE
- City
- Elmhurst
- State
- NY
- ZIP
- 11373
- Country
- US
- [email protected]
- Phone
- 332 2015192
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Propoxyphene, Employment And Insurance Testing, Exempt | PVI | Class 2 | Clinical Toxicology | No | 2024-08-23 |
| Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | CDT | Class 1 | Clinical Chemistry | No | 2024-01-22 |
| Test System, Nicotine, Cotinine, Metabolites | MRS | Class 1 | Clinical Toxicology | No | 2024-08-23 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2024-08-23 |
| Test, Morphine, Employment And Insurance Testing, Exempt | PVG | Class 2 | Clinical Toxicology | No | 2024-08-23 |
| Test, Methaqualone, Employment And Insurance Testing, Exempt | PVF | Class 2 | Clinical Toxicology | No | 2024-08-23 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2024-08-23 |
| Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt | PVK | Class 2 | Clinical Toxicology | No | 2024-08-23 |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | PVJ | Class 2 | Clinical Toxicology | No | 2024-08-23 |
| Test, Benzodiazepine, Employment And Insurance Testing, Exempt | PUZ | Class 2 | Clinical Toxicology | No | 2024-08-23 |
| Control, Fecal Occult Blood | OSL | Class 2 | Hematology | No | 2025-05-20 |
| Test, Methamphetamine, Employment And Insurance Testing, Exempt | PVD | Class 2 | Clinical Toxicology | No | 2024-08-23 |
| Kit, Identification, Mycobacteria | JSY | Class 1 | Microbiology | No | 2025-05-20 |
| Test, Amphetamine, Employment And Insurance Testing, Exempt | PUX | Class 2 | Clinical Toxicology | No | 2024-08-23 |
| Test, Opiates, Employment And Insurance Testing, Exempt | PVH | Class 2 | Clinical Toxicology | No | 2024-08-23 |
| Test, Methadone, Employment And Insurance Testing, Exempt | PVE | Class 2 | Clinical Toxicology | No | 2024-08-23 |
| Test, Codeine, Employment And Insurance Testing, Exempt | PVB | Class 2 | Clinical Toxicology | No | 2024-08-23 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2024-01-22 |
| Test, Barbiturate, Employment And Insurance Testing, Exempt | PUY | Class 2 | Clinical Toxicology | No | 2024-08-23 |
| Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt | PVA | Class 2 | Clinical Toxicology | No | 2024-08-23 |
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2024-01-22 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2024-01-17 |
Proprietary Names
Propoxyphene Rapid Test Strip; Propoxyphene Rapid Test Cassette; Propoxyphene Rapid Test Panel
Blood Lipid Analysis System(LPM-101, LPM- 102)
Triglycerides Test Strip (Dry Chemistry)(TGS-101)
Blood Lipid Test Strip (Dry Chemistry)(LPS-101)
Cotinine Rapid Test Strip ; Cotinine Rapid Test Cassette ; Cotinine Rapid Test Panel
Luteinizing Hormone Rapid Test Strip; Luteinizing Hormone Rapid Test Cassette
Morphine Rapid Test Strip; Morphine Rapid Test Cassette; Morphine Rapid Test Panel
Multi-Drug Rapid Test (Urine)
Methaqualone Rapid Test Strip; Methaqualone Rapid Test Cassette; Methaqualone Rapid Test Panel
FOLLICLE STIMULATING HORMONE Rapid Test Strip; FOLLICLE STIMULATING HORMONE Rapid Test Cassette
One Step FSH Test Strips (Urine)
Tricyclic antidepressant Rapid Test Strip; Tricyclic antidepressant Rapid Test Cassette
Tricyclic antidepressant Rapid Test Panel
Cannabinoid Rapid Test Strip; Cannabinoid Rapid Test Cassette; Cannabinoid Rapid Test Panel
Marijuana (THC) Rapid Test (Urine); Marijuana (THC) Test Strips
Benzodiazepine Rapid Test Strip; Benzodiazepine Rapid Test Cassette; Benzodiazepine Rapid Test Panel
Immunochemical Fecal Occult Blood Test Kit
Immunochemical Fecal Occult Blood Test Kit; Immunochemical Fecal Occult Blood (FOB) Test Kit
Methamphetamine Rapid Test Strip; Methamphetamine Rapid Test Cassette; Methamphetamine Rapid Test Panel
H. pylori Rapid Test Kit
Amphetamine Rapid Test Strip; Amphetamine Rapid Test Cassette; Amphetamine Rapid Test Panel
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
Methadone Rapid Test Strip; Methadone Rapid Test Cassette; Methadone Rapid Test Panel
Codeine Rapid Test Strip; Codeine Rapid Test Cassette; Codeine Rapid Test Panel
Total Cholesterol Test Strip
Blood Lipid Analysis System(LPM-101, LPM-102)
Total Cholesterol Meter
Barbiturate Rapid Test Strip; Barbiturate Rapid Test Cassette; Barbiturate Rapid Test Panel
Cocaine Rapid Test Strip ; Cocaine Rapid Test Cassette ; Cocaine Rapid Test Panel
High Density Lipoprotein Cholesterol Test Strip (Dry Chemistry)(HLS-101)
Uric Acid Meter (GUM-102)
Uric Acid Test Strip(Dry Chemistry)( UAS-101)
Establishment Types
Manufacture Medical Device