Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021986677

FEI Number

3021986677

Entity Name

HANGZHOU TONGZHOU BIOTECHNOLOGY CO., LTD

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

No. 1 Ninghong Road, Donghu Street, Linping District, Hangzhou Zhejiang 311199, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hangzhou Tongzhou Biotechnology Co., Ltd (Owner Number: 10084418)

Owner / Operator Contact Address

No. 1 Ninghong Road, Donghu Street, Linping District, Hangzhou, CN-ZJ 311199, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AMPHETAMINE(AMP) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Barbiturate(BAR) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Propoxyphene(PPX) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT TRICYCLIC ANTIDEPRESSANT Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT CODEINE Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Opiates(OPI) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Methadone(MTD) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Methaqualone(MQL) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Morphine(MOP) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT luteinizing hormone Rapid Test Benzodiazepines(BZO) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUX	Test, Amphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3100	2024-10-25
PUY	Test, Barbiturate, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3150	2024-10-30
PVI	Test, Propoxyphene, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3700	2024-10-29
PVK	Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3910	2024-10-30
PVB	Test, Codeine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3270	2024-10-30
PVH	Test, Opiates, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3650	2024-10-29
PVE	Test, Methadone, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3620	2024-10-30
PVF	Test, Methaqualone, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3630	2024-10-30
PVG	Test, Morphine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3640	2024-10-29
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2022-02-18
PUZ	Test, Benzodiazepine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3170	2024-10-30

Official Correspondent

Tony Shao

US Agent Details

Joseph Fan Business: Acro Biotech Inc Email: manuel@acrobiotech.com Phone: (310) 4666892

Related Public Records

Same Entity

Hangzhou Tongzhou Biotechnology Co., Ltd

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

View Entity Profile →

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
3023322455	GUANGZHOU WONDFO BIOTECH CO., LTD.	Guangzhou Guangdong, CN
3003917514	BTNX Inc.	Pickering Ontario, CA
3043534289	MOHE BioTech Production (Mauritius) Ltd.	MOKA, MU
3008517993	ZHEJIANG ORIENT GENE BIOTECH	Huzhou Zhejiang, CN
3011522054	Hangzhou Biotest Biotech Co.,Ltd.	Hangzhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021986677. Last updated year: 2026. Please use registration number 3021986677 when referencing this establishment in official correspondence.