Data / Medical devices / China / Hangzhou Laihe Biotech Co.,ltd.
Hangzhou Laihe Biotech Co.,ltd.: FDA-registered device maker in Hangzhou Zhejiang, China, 3 510(k) clearances
Hangzhou Laihe Biotech Co.,ltd. is registered with the FDA (registration 3016610313) in Hangzhou Zhejiang, China. It lists 10 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 18, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016610313
- Address
- Room, F1-3, Building 1, No.425 Miaohouwang Road, Xixing Street, Binjiang District, Hangzhou Zhejiang, China, 310051
- Owner or operator
- Hangzhou Laihe Biotech Co.,Ltd. (10065287)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 28, 2020
- Registered through
- 2026
- Brand names listed
- Amphetamine (AMP)one step rapid test cassette, Amphetamine (AMP)one step rapid test dipcard, Cocaine (COC) one step rapid test cassette, Cocaine (COC) one step rapid test dipcard, Genabio COVID-19 Rapid Self-Test Kit, LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold), LYHER® Oral fluid Multi-Drug Test Kit (Cube), LYHER® Urine Marijuana (THC) Test Kit(Cassette) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | QKP | N | Contract manufacturer | accessdata.fda.gov |
| Enzyme Immunoassay, Amphetamine | DKZ | 2 | Manufacturer | accessdata.fda.gov |
| Enzyme Immunoassay, Cannabinoids | LDJ | 2 | Manufacturer | accessdata.fda.gov |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | 2 | Manufacturer | accessdata.fda.gov |
| Enzyme Immunoassay, Opiates | DJG | 2 | Manufacturer | accessdata.fda.gov |
| Enzyme Immunoassay, Phencyclidine | LCM | U | Manufacturer | accessdata.fda.gov |
| Reagent, Coronavirus Serological | QKO | N | Manufacturer | accessdata.fda.gov |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | 1 | Manufacturer | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Manufacturer | accessdata.fda.gov |
| Thin Layer Chromatography, Methamphetamine | DJC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 18, 2025 | K240287 | LYHER® Oral fluid Multi-Drug Test Kit (Cube) | DJC | Substantially Equivalent | Hangzhou Laihe Biotech Co., Ltd. | accessdata.fda.gov |
| January 10, 2024 | K232604 | LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) | LDJ | Substantially Equivalent | Hangzhou Laihe Biotech Co., Ltd. | accessdata.fda.gov |
| January 9, 2024 | K232597 | LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) | DJG | Substantially Equivalent | Hangzhou Laihe Biotech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Enzyme Immunoassay, Opiates
- All makers of Enzyme Immunoassay, Amphetamine
- All makers of Enzyme Immunoassay, Phencyclidine
- All makers of Thin Layer Chromatography, Methamphetamine
- All makers of Enzyme Immunoassay, Cocaine And Cocaine Metabolites
- All makers of Enzyme Immunoassay, Cannabinoids
Updated March 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.