Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021010433

FEI Number

3021010433

Entity Name

HANGZHOU LYSUN BIOTECHNOLOGY CO.LTD

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

6th Floor,6th Building, No. 95 Binwen Road, Xixin Street, Binjiang District, Hangzhou Zhejiang 310053, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HANGZHOU LYSUN BIOTECHNOLOGY CO.LTD (Owner Number: 10089876)

Owner / Operator Contact Address

6th Floor,6th Building, No. 95 Binwen Road, Xixin Street, Binjiang District, Hangzhou, CN-ZJ 310053, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 Multi-Drug Rapid Test (Urine) 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 Multi-Drug Rapid Test (Urine) Methamphetamine Rapid Test Strip; Methamphetamine Rapid Test Cassette; Methamphetamine Rapid Test Panel H. pylori Rapid Test Kit Multi-Drug Rapid Test (Urine) 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PVI	Test, Propoxyphene, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3700	2024-08-23
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2024-01-22
MRS	Test System, Nicotine, Cotinine, Metabolites	Clinical Toxicology	Class 1	862.3220	2024-08-23
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2024-08-23
PVG	Test, Morphine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3640	2024-08-23
PVF	Test, Methaqualone, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3630	2024-08-23
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2024-08-23
PVK	Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3910	2024-08-23
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3870	2024-08-23
PUZ	Test, Benzodiazepine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3170	2024-08-23
OSL	Control, Fecal Occult Blood	Hematology	Class 2	864.6550	2025-05-20
PVD	Test, Methamphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3610	2024-08-23
JSY	Kit, Identification, Mycobacteria	Microbiology	Class 1	866.2660	2025-05-20
PUX	Test, Amphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3100	2024-08-23
PVH	Test, Opiates, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3650	2024-08-23

Official Correspondent

Jake Chen

US Agent Details

Andy Smith Business: GRZAN GROUP INC. Email: info@grzan-ar.com Phone: (332) 2015192

Related Public Records

Same Entity

HANGZHOU LYSUN BIOTECHNOLOGY 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
K832444	Stanbio Laboratory	ENZYMATIC TRIGLYCERIDES #2000	1983-08-31
K133067	Siemens Healthcare Diagnostics, Inc.	ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT	2013-11-22

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

Similar Registrations

Registration Number	Establishment Name	Location
3012073813	Hangzhou AllTest Biotech Co.,Ltd	Hangzhou Zhejiang, CN
3021986677	HANGZHOU TONGZHOU BIOTECHNOLOGY CO., LTD	Hangzhou Zhejiang, CN
3003917514	BTNX Inc.	Pickering Ontario, CA
3027519599	Hangzhou AllTest Biotech Co.,Ltd	Hangzhou Zhejiang, CN
3006048451	Confirm Biosciences LLC	SAN DIEGO, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021010433. Last updated year: 2026. Please use registration number 3021010433 when referencing this establishment in official correspondence.