Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016610313

FEI Number

3016610313

Entity Name

HANGZHOU LAIHE BIOTECH CO.,LTD.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

Room 401-406, F1-3, Building 1, No.425 Miaohouwang Road, Xixing Street, Binjiang District, Hangzhou Zhejiang 310051, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hangzhou Laihe Biotech Co.,Ltd. (Owner Number: 10065287)

Owner / Operator Contact Address

Room 401-406, F1-3, Building 1, No.425 Miaohouwang Road, Xixing Street, Binjiang District, Hangzhou, CN-ZJ 310051, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240287

PMA Number

N/A

All Registered 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)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2020-03-28
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2023-05-04
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2024-04-18
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2022-09-06
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2024-01-15
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2024-01-15
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2024-01-15
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2024-01-15
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2024-01-15
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2024-01-15
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2025-03-31
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2025-03-31
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2025-03-31
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2025-03-31
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2025-03-31
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2025-03-31

Official Correspondent

Yun Ouyang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Hangzhou Laihe Biotech Co.,Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K110182	Guangzhou Wondfo Biotech Co., Ltd.	CANNABINOIDS URINE TEST	2011-05-20
K121557	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST	2012-07-25
K920418	Instrumentation Laboratory CO	IL TEST CANNABINOID, 35282	1992-02-27
K924751	Solarcare Technologies Corp,Inc.	SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY	1992-12-11
K142044	Guangzhou Wondfo Biotech Co., Ltd.	CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE	2014-08-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01
Z-0001-2023	Jiangsu Well Biotech Co., Ltd. No	N	Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Z-0006-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0007-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0008-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016610313. Last updated year: 2026. Please use registration number 3016610313 when referencing this establishment in official correspondence.