FDA Registration
Active
🇨🇳 China
HANGZHOU LAIHE BIOTECH CO.,LTD.
Reg #: 3016610313
·
FEI: 3016610313
·
Expires 2026
Products
10
Proprietary Names
28
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- HANGZHOU LAIHE BIOTECH CO.,LTD.
- Registration Number
- 3016610313
- FEI Number
- 3016610313
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 401-406, F1-3, Building 1, No.425 Miaohouwang Road, Xixing Street, Binjiang District
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K232597
Owner / Operator
- Firm Name
- Hangzhou Laihe Biotech Co.,Ltd.
- Operator Number
- 10065287
- Address
- Room 401-406, F1-3, Building 1, No.425 Miaohouwang Road, Xixing Street, Binjiang District
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 310051
- Country
- CN
- Correspondent
- Yun Ouyang
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2020-03-28 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2023-05-04 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2024-04-18 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2022-09-06 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2024-01-15 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2024-01-15 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2024-01-15 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2024-01-15 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2024-01-15 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2024-01-15 |
Proprietary Names
LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)
femometer Fertility Tracking Kit
femometer Fertility Tests (Refill)
femometer FM-IVY-103 with Femometer Period Tracker app
Ovulation Tracker
Menopause Tests (Refill)
Menopause Test Kit
Genabio COVID-19 Rapid Self-Test Kit
LYHER® Urine Multi-Drug Test Kit(Cup)
LYHER® Urine Multi-Drug Test Kit(Cassette)
Phencyclidine (PCP) One step rapid test dipcard
Phencyclidine (PCP) One step rapid test cassette
Opiates(OPI) One step rapid test dipcard
LYHER® Urine Multi-Drug Test Kit(Dipcard)
Multi drugs one step rapid test kit (MET/THC)
Cocaine (COC) one step rapid test cassette
Opiates(OPI) One step rapid test cassette
Amphetamine (AMP)one step rapid test dipcard
Marijuana (THC) one step rapid test dipcard
Marijuana (THC) one step rapid test cassette
Cocaine (COC) one step rapid test dipcard
Methamphetamine (MET) One step rapid test dipcard
Methamphetamine (MET) One step rapid test cassette
Amphetamine (AMP)one step rapid test cassette
LYHER® Oral fluid Multi-Drug Test Kit (Cube)
Marijuana (THC) one step rapid test strip
LYHER® Urine Marijuana (THC) Test Kit(Cassette)
LYHER® Urine Marijuana (THC) Test Kit(Strip)
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)