Hangzhou Laihe Biotech Co., Ltd.
Manufacturer and brand owner in Hangzhou, Zhejiang, China. 10 device types, 6 products catalogued, 3 clearances.
Hangzhou Laihe Biotech Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Enzyme Immunoassay, Opiates, Enzyme Immunoassay, Amphetamine and 8 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
10device types registered with the FDA
6products catalogued under its own name
3510(k) clearances
Registration
| Registered name | HANGZHOU LAIHE BIOTECH CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016610313 |
| FEI number | 3016610313 |
| DUNS | 543330912 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 杭州莱和生物技术有限公司 |
|---|---|
| Unified social credit code | 91330108589866519M |
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | Room 401-406, F1-3, Building 1, No.425 Miaohouwang Road, Xixing Street, Binjiang District |
| Postal code | 310051 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | Class N | Genabio COVID-19 Rapid Self-Test Kit | 2022 | 12 |
| Enzyme Immunoassay, Amphetamine | Class 2 | LYHER® Urine Multi-Drug Test Kit(Cup), Amphetamine (AMP)one step rapid test dipcard, Phencyclidine (PCP) One step rapid test cassette, Methamphetamine (MET) One step rapid test cassette, Phencyclidine (PCP) One step rapid test dipcard, Marijuana (THC) one step rapid test dipcard and 11 more | 2024 | 16 |
| Enzyme Immunoassay, Cannabinoids | Class 2 | LYHER® Urine Multi-Drug Test Kit(Cup), Amphetamine (AMP)one step rapid test dipcard, Phencyclidine (PCP) One step rapid test cassette, Methamphetamine (MET) One step rapid test cassette, Phencyclidine (PCP) One step rapid test dipcard, Marijuana (THC) one step rapid test dipcard and 14 more | 2024 | 18 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Class 2 | LYHER® Urine Multi-Drug Test Kit(Cup), Amphetamine (AMP)one step rapid test dipcard, Phencyclidine (PCP) One step rapid test cassette, Methamphetamine (MET) One step rapid test cassette, Phencyclidine (PCP) One step rapid test dipcard, Marijuana (THC) one step rapid test dipcard and 11 more | 2024 | 16 |
| Enzyme Immunoassay, Opiates | Class 2 | LYHER® Urine Multi-Drug Test Kit(Cup), Amphetamine (AMP)one step rapid test dipcard, Phencyclidine (PCP) One step rapid test cassette, Methamphetamine (MET) One step rapid test cassette, Phencyclidine (PCP) One step rapid test dipcard, Marijuana (THC) one step rapid test dipcard and 11 more | 2024 | 17 |
| Enzyme Immunoassay, Phencyclidine | Class U | LYHER® Urine Multi-Drug Test Kit(Cup), Amphetamine (AMP)one step rapid test dipcard, Phencyclidine (PCP) One step rapid test cassette, Methamphetamine (MET) One step rapid test cassette, Phencyclidine (PCP) One step rapid test dipcard, Marijuana (THC) one step rapid test dipcard and 11 more | 2024 | 16 |
| Reagent, Coronavirus Serological | Class N | LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) | 2020 | 12 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Class 1 | Menopause Test Kit, Menopause Tests (Refill) | 2024 | 30 |
| Test, Luteinizing Hormone (Lh), Over The Counter | Class 1 | LittleBegin Ovulation (LH) Test Strip, LittleBegin, LittleBegin Ovulation (LH) Tracking Kit, LittleBegin Ovulation Test Kit, LittleBegin Fertility LH Strip, femometer Fertility Tracking Kit and 10 more | 2023 | 38 |
| Thin Layer Chromatography, Methamphetamine | Class 2 | LYHER® Urine Multi-Drug Test Kit(Cup), Amphetamine (AMP)one step rapid test dipcard, Phencyclidine (PCP) One step rapid test cassette, Methamphetamine (MET) One step rapid test cassette, Phencyclidine (PCP) One step rapid test dipcard, Marijuana (THC) one step rapid test dipcard and 11 more | 2024 | 12 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| LittleBegin | NGE | 3 |
| femometer | NGE | 2 |
| Lyher | DIO | 2 |
| Lyher | LDJ | 2 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K240287 | 2025-03-18 | DJC | Traditional | This company |
| K232604 | 2024-01-10 | LDJ | Traditional | This company |
| K232597 | 2024-01-09 | DJG | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2012 |
|---|---|
| Employees | 120 |
| Factory area | 9200 |
| Main products | Rapid test kits, Drugs of abuse tests, Respiratory disease tests, Women’s health tests |
| Certifications | ISO 13485 |
| Export markets | 80+ countries |
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.
The manufacturer named here can complete this record.