Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008517993

FEI Number

3008517993

Entity Name

ZHEJIANG ORIENT GENE BIOTECH

City/State/Country

Huzhou Zhejiang, CN

Establishment Address

3787 East Yangguang Avenue, Dipu Street, Anji, Huzhou Zhejiang 313300, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Zhejiang Orient Gene Biotech Co., Ltd (Owner Number: 10033347)

Owner / Operator Contact Address

3787#, East Yangguang Avenue, Dipu Street Anji, Huzhou, CN-ZJ 313300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Healgen Scientific LLC Healgen 800 Urine Analyzer Healgen Scientific LLC Healgen Reagent Strip for Urinalysis (Manual - Qualitative) Healgen Scientific LLC Healgen 500 Urine Analyzer Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card healgen healgen Healgen Healgen Scientific LLC, Healgen Rapid Check COVID-19/Flu A&B Antigen Test Healgen Scientific LLC, Healgen Rapid Check COVID-19/Flu A&B Antigen Test PRO Healgen hCG One Step Pregnancy Test strip Healgen hCG One Step Pregnancy Test Cassette healgen Healgen Scientific LLC. Rapid Check RSV Antigen Test Cassette Healgen Scientific LLC Rapid Check RSV Antigen Test (Nasopharyngeal swabs) Healgen healgen healgen Healgen Oxazepam Test Cassette Virginia Kendall Corporation Ucheck Morphine Test Strip Budpak Inc. Budpak Morphine Test Cassette Healgen Morphine Test Cup Budpak Inc. Budpak Morphine Test DipCard Healgen Morphine Test Strip Virginia Kendall Corporation Budpak Morphine Test Strip Budpak Inc. Budpak Morphine Test Strip Healgen Oxazepam Test Strip Healgen Morphine Test Cassette Healgen Oxazepam Test Cup Healgen Morphine Test Dip Card SCI Medical Group U-Check Opioid Home Drug (Test Strip) Healgen Oxazepam Test Dip Card Healgen® Accurate Rapid Fentanyl Test Cassette (Urine) Healgen® Accurate Fentanyl Rapid Test Strip (Urine) Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine) Healgen® Accurate Fentanyl Rapid Test Cassette (Urine) Healgen® Accurate Rapid Fentanyl Test Strip (Urine) Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine) Healgen Healgen Scientific LLC Healgen Multi-Drug Urine Test Dip Card Healgen Scientific LLC Healgen Multi-Drug Urine Test Cup healgen Healgen Scientific LLC., LH Luteinizing Hormone Test Healgen Accurate Home Urine Drug Test Dip Card Healgen Accurate Urine Drug Screen Dip Card HEALGEN SCIENTIFIC LLC Healgen Phencyclidine Test Cup HEALGEN SCIENTIFIC LLC Healgen MDMA (Ecstasy) Test Cassette HEALGEN SCIENTIFIC LLC Healgen MDMA (Ecstasy) Test Dip Card HEALGEN SCIENTIFIC LLC Healgen Phencyclidine Test Dip Card HEALGEN SCIENTIFIC LLC Healgen MDMA (Ecstasy) Test Strip HEALGEN SCIENTIFIC LLC Healgen Phencyclidine Test Cassette HEALGEN SCIENTIFIC LLC Healgen Phencyclidine Test Strip HEALGEN SCIENTIFIC LLC Healgen MDMA (Ecstasy) Test Cup healgen Healgen Oxycodone Test Cup Healgen Amphetamine Test Cup Healgen Amphetamine Test Dip Card Healgen Amphetamine Test Cassette Healgen Oxycodone Test Cassette Healgen Oxycodone Test Dip Card Healgen Amphetamine Test Strip Healgen Oxycodone Test Strip healgen healgen Life2O Full Panel Liver Function Urinalysis Test Healgen Life2O Full Panel Liver Function Urinalysis Test Healgen Scientific LLC Strep A Antigen Test Healgen Scientific LLC Strep A Rapid Test Strip (Throat Swab)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2014-04-09
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2014-04-09
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2014-04-09
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2014-04-09
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2014-04-09
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2014-04-09
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2014-04-09
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2014-04-09
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2014-04-09
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2014-04-09
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2014-04-09
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2014-04-09
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2026-01-15
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2026-01-15
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2026-01-15
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2026-01-15
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2026-01-15
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2026-01-15
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2026-01-15
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2026-01-15
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2026-01-15
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2026-01-15
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2026-01-15
MKU	Enzyme Immunoassay, Nicotine And Nicotine Metabolites	Clinical Toxicology	Class 1	862.3220	2023-05-19
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2023-05-19
PUX	Test, Amphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3100	2019-01-04
QVF	Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings	Microbiology	Class 2	866.3982	2024-04-22
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2010-08-05
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2020-02-27
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2015-09-18
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2015-09-18
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2015-09-18
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2016-07-01
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2025-06-03
JZW	Nephelometer	Immunology	Class 1	866.4540	2010-08-09
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2010-08-06
LHD	Device, Fertility Diagnostic, Proceptive	Unknown	Class U	N/A	2017-03-28
PVD	Test, Methamphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3610	2019-01-04
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2022-06-16
SCA	Multi-Analyte Respiratory Virus Antigen Detection Test	Microbiology	Class 2	866.3987	2024-10-09
PVA	Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3250	2019-01-04
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2013-12-27
JQB	Kinetic Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2010-08-05
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2023-08-23
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2010-08-06
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2020-07-28
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2020-02-27
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2020-08-07
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2016-07-01
JJI	Analyzer, Enzyme, For Clinical Use	Clinical Chemistry	Class 1	862.2500	2010-08-05
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2020-03-20
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2022-03-17
MRS	Test System, Nicotine, Cotinine, Metabolites	Clinical Toxicology	Class 1	862.3220	2019-01-04
JLO	Enzymatic (Glutathione Reductase), Glutathione	Clinical Chemistry	Class 1	862.1365	2010-08-05
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2020-02-27
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2022-09-06
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2022-09-06
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2022-09-06
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2022-09-06
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2022-09-06
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2022-09-06
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2022-09-06
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2022-09-06
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2022-09-06
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2022-09-06
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2022-09-06
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2015-01-13
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2015-01-13
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-10-09
PVG	Test, Morphine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3640	2019-01-04
DIC	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	Clinical Toxicology	Class 2	862.3040	2020-10-20
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2023-02-03
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2021-04-30
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2011-08-02
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2010-08-06
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2026-04-28
MKU	Enzyme Immunoassay, Nicotine And Nicotine Metabolites	Clinical Toxicology	Class 1	862.3220	2026-04-28
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2015-05-15
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2015-05-15
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2015-05-15
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2015-05-15
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2015-05-15
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2015-05-15
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2026-04-28
QYT	Over-The-Counter Covid-19 Antigen Test	Microbiology	Class 2	866.3984	2026-04-22
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2010-08-05
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2010-08-12
PVI	Test, Propoxyphene, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3700	2019-01-03
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2024-04-22
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2024-04-22
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2024-04-22
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2024-04-22
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-04-22
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2024-04-22
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2024-04-22
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2024-04-22
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2024-04-22
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2024-04-22
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2024-04-22
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2015-08-19
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2015-08-19
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2015-08-19
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2015-08-19
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2015-08-19
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2015-08-19
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2015-08-19
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2015-08-19
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2015-08-19
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2015-03-24
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2015-03-24
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2022-06-16
JGY	Colorimetric Method, Triglycerides	Clinical Chemistry	Class 1	862.1705	2010-08-05
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2015-01-13
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2015-01-13
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2015-02-09
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2015-02-09
JHN	Turbidimetric Method, Lipoproteins	Clinical Chemistry	Class 1	862.1475	2010-08-05
CET	Olive Oil Emulsion (Turbidimetric), Lipase	Clinical Chemistry	Class 1	862.1465	2010-08-05
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2011-09-26
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2022-06-16
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2010-08-06
PVF	Test, Methaqualone, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3630	2019-01-04
LNW	Paper, Obstetric Ph	Clinical Chemistry	Class 1	862.1550	2021-11-19
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2020-03-20
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2022-06-16
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3870	2019-01-03
PVB	Test, Codeine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3270	2019-01-04
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2022-03-17

Official Correspondent

JIANQIU FANG

US Agent Details

JIANQIU FANG Email: fang.bryan@yahoo.com Phone: (281) 8571217

Related Public Records

Same Entity

Zhejiang Orient Gene 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
K885053	Biotrol, USA, Inc.	BIOTROL URINE PROTEINS REAGENT	1989-01-30
K101852	Iris International Inc., A Division of Iris Iris I	CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT	2011-03-23
K252550	Guangzhou Wondfo Biotech Co., Ltd.	SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx	2025-11-18
K202567	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx	2020-09-25
K260065	Guangzhou Wondfo Biotech Co., Ltd.	SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx	2026-04-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0081-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.
Z-0082-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status Connect System The Clinitek Status system is a urine analyzer.
Z-0083-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008517993. Last updated year: 2026. Please use registration number 3008517993 when referencing this establishment in official correspondence.