Zhejiang Orient Gene Biotech

Manufacturer and brand owner in Huzhou, Zhejiang, China. 86 device types, 3 products catalogued.

Registry build 21.09.26

Zhejiang Orient Gene Biotech is a contract manufacturer holding a current FDA establishment registration. The registration covers Fluorometer, Nephelometer and 84 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2010.

86device types registered with the FDA
3products catalogued under its own name

Registration

FDA registration record for Zhejiang Orient Gene Biotech
Registered name ZHEJIANG ORIENT GENE BIOTECH
Status Registered
Registration expires 2026
Registration number 3008517993
FEI number 3008517993
DUNS 421148715
Establishment type Contract manufacturer, Complaint-file establishment, Manufacturer, Exporter

Chinese Registration

Chinese company register details for Zhejiang Orient Gene Biotech
Chinese legal name 浙江东方基因生物制品股份有限公司
Unified social credit code 913305007804719612
Source export sales certificate, Zhejiang medical products administration

Location

Address of Zhejiang Orient Gene Biotech
City Huzhou
Province Zhejiang
Address 3787 East Yangguang Avenue
Postal code 313300
Country China

What It Makes

Device types Zhejiang Orient Gene Biotech is registered to make
Device type Class Listed under the names Listed since Chinese makers
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) Class 1 Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer, Healgen Scientific LLC Healgen 500 Urine Analyzer, Healgen Scientific LLC Healgen Reagent Strip for Urinalysis (Manual – Qualitative), Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} 2014 10
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method Class 2 2020 2
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Class 1 Healgen 2010 16
Analyzer, Enzyme, For Clinical Use Class 1 healgen 2010 3
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus Class 1 Healgen Scientific LLC. Rapid Check RSV Antigen Test Cassette, Healgen Scientific LLC Rapid Check RSV Antigen Test (Nasopharyngeal swabs) 2022 4
Antigens, All Groups, Streptococcus Spp. Class 1 Healgen Scientific LLC Strep A Rapid Test Strip (Throat Swab), Healgen Scientific LLC Strep A Antigen Test 2022 6
Automated Urinalysis System Class 1 Healgen, Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer, Healgen Scientific LLC Healgen 500 Urine Analyzer, Healgen Scientific LLC Healgen Reagent Strip for Urinalysis (Manual – Qualitative), Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} 2010 16
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Class 1 Life2O Full Panel Liver Function Urinalysis Test, Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer, Healgen Scientific LLC Healgen 500 Urine Analyzer, Healgen Scientific LLC Healgen Reagent Strip for Urinalysis (Manual – Qualitative), Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} 2014 12
Biuret (Colorimetric), Total Protein Class 2 healgen 2010 3
Blood, Occult, Colorimetric, In Urine Class 2 Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer, Healgen Scientific LLC Healgen 500 Urine Analyzer, Healgen Scientific LLC Healgen Reagent Strip for Urinalysis (Manual – Qualitative), Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} 2014 5
Clinical Sample Concentrator Class 1 2021 27
Colorimeter, Photometer, Spectrophotometer For Clinical Use Class 1 Healgen 2010 13
Colorimetric Method, Triglycerides Class 1 healgen 2010 5
Container, Specimen, Sterile Class 1 2019 79
Control, Fecal Occult Blood Class 2 External Controls → Second Generation FOB Rapid Test Cassette 2026 3
Coronavirus Antigen Detection Test System. Class N 2020 12
Covid-19 Multi-Analyte Antigen Device Class N Healgen COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) 2024 7
Densitometeric, Protein Fractionation Class 1 healgen 2010 1
Device, Fertility Diagnostic, Proceptive Class U 2017 3
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Class 1 Healgen Scientific LLC, URcheck URS Test Strip, Healgen Scientific LLC URcheck UTI Test Strip, Easy Healthcare Corporation easy@Home Urinary Tract Infection Test, Healgen Scientific LLC, Healgen URS Test Strip, Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer and 4 more 2014 14
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Class 1 Life2O Full Panel Liver Function Urinalysis Test, Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer, Healgen Scientific LLC Healgen 500 Urine Analyzer, Healgen Scientific LLC Healgen Reagent Strip for Urinalysis (Manual – Qualitative), Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} 2014 11
Dye-Indicator, Ph (Urinary, Non-Quantitative) Class 1 Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer, Healgen Scientific LLC Healgen 500 Urine Analyzer, Healgen Scientific LLC Healgen Reagent Strip for Urinalysis (Manual – Qualitative), Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} 2014 16
Enzymatic (Glutathione Reductase), Glutathione Class 1 healgen 2010 2
Enzymatic Esterase–Oxidase, Cholesterol Class 1 healgen 2010 9
Enzyme Immunoassay, Amphetamine Class 2 Healgen Scientific LLC Healgen Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Multi-Drug Urine Test Dip Card, Healgen Amphetamine Test Dip Card, Healgen Amphetamine Test Strip, Healgen Amphetamine Test Cup, Healgen Amphetamine Test Cassette and 5 more 2015 16
Enzyme Immunoassay, Barbiturate Class 2 Healgen Scientific LLC Healgen Secobarbital Test Dip Card, Healgen Scientific LLC Healgen Secobarbital Test Cup, Healgen Scientific LLC Healgen Methadone Test Cup, Healgen Scientific LLC Healgen Buprenorphine Test Strip, Healgen Scientific LLC Healgen Methadone Test Cassette, Healgen Scientific LLC Healgen Buprenorphine Test Cup and 9 more 2015 12
Enzyme Immunoassay, Benzodiazepine Class 2 Healgen Scientific LLC Healgen Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Multi-Drug Urine Test Dip Card, Healgen Morphine Test Cassette, SCI Medical Group U-Check Opioid Home Drug (Test Strip), Healgen Oxazepam Test Strip, Healgen Oxazepam Test Cassette and 11 more 2015 13
Enzyme Immunoassay, Cannabinoids Class 2 Healgen Scientific LLC Healgen Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Multi-Drug Urine Test Dip Card, Healgen Scientific LLC Accurate Urine DOA Rapid Test Dipcard 2015 18
Enzyme Immunoassay, Cocaine And Cocaine Metabolites Class 2 Healgen Scientific LLC Healgen Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Multi-Drug Urine Test Dip Card, Healgen Scientific LLC Accurate Urine DOA Rapid Test Dipcard 2015 16
Enzyme Immunoassay, Methadone Class 2 Healgen Scientific LLC Healgen Secobarbital Test Dip Card, Healgen Scientific LLC Healgen Secobarbital Test Cup, Healgen Scientific LLC Healgen Methadone Test Cup, Healgen Scientific LLC Healgen Buprenorphine Test Strip, Healgen Scientific LLC Healgen Methadone Test Cassette, Healgen Scientific LLC Healgen Buprenorphine Test Cup and 9 more 2015 11
Enzyme Immunoassay, Nicotine And Nicotine Metabolites Class 1 2023 2
Enzyme Immunoassay, Opiates Class 2 Healgen Scientific LLC Healgen Secobarbital Test Dip Card, Healgen Scientific LLC Healgen Secobarbital Test Cup, Healgen Scientific LLC Healgen Methadone Test Cup, Healgen Scientific LLC Healgen Buprenorphine Test Strip, Healgen Scientific LLC Healgen Methadone Test Cassette, Healgen Scientific LLC Healgen Buprenorphine Test Cup and 31 more 2015 17
Enzyme Immunoassay, Phencyclidine Class U Healgen Scientific LLC Accurate Urine DOA Rapid Test Dipcard, Healgen Scientific LLC Healgen Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Multi-Drug Urine Test Dip Card, HEALGEN SCIENTIFIC LLC Healgen Phencyclidine Test Dip Card, HEALGEN SCIENTIFIC LLC Healgen Phencyclidine Test Strip, HEALGEN SCIENTIFIC LLC Healgen Phencyclidine Test Cup and 5 more 2015 16
Enzyme Immunoassay, Propoxyphene Class 2 2015 10
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Class 1 Healgen 2010 72
Fluorometer Class 1 healgen 2010 8
Gas Chromatography, Methamphetamine Class 2 Healgen Scientific LLC Healgen Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Multi-Drug Urine Test Dip Card, Healgen Scientific LLC Accurate Urine DOA Rapid Test Dipcard, HEALGEN SCIENTIFIC LLC Healgen Phencyclidine Test Dip Card, HEALGEN SCIENTIFIC LLC Healgen Phencyclidine Test Strip, HEALGEN SCIENTIFIC LLC Healgen Phencyclidine Test Cup and 5 more 2015 10
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Class 1 Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer, Healgen Scientific LLC Healgen 500 Urine Analyzer, Healgen Scientific LLC Healgen Reagent Strip for Urinalysis (Manual – Qualitative), Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} 2014 14
Kinetic Method, Gamma-Glutamyl Transpeptidase Class 1 healgen 2010 1
Kit, Test, Pregnancy, Hcg, Over The Counter Class 2 Healgen hCG One Step Pregnancy Test strip, Healgen hCG One Step Pregnancy Test Cassette 2011 30
Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Class 2 Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer, Healgen Scientific LLC Healgen 500 Urine Analyzer, Healgen Scientific LLC Healgen Reagent Strip for Urinalysis (Manual – Qualitative), Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} 2014 5
Multi-Analyte Respiratory Virus Antigen Detection Test Class 2 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 2024 4
Nadh Oxidation/Nad Reduction, Alt/Sgpt Class 1 healgen 2010 3
Nephelometer Class 1 healgen 2010 4
Nephelometer, For Clinical Use Class 1 healgen 2010 2
Nitroprusside, Ketones (Urinary, Non-Quant.) Class 1 Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer, Healgen Scientific LLC Healgen 500 Urine Analyzer, Healgen Scientific LLC Healgen Reagent Strip for Urinalysis (Manual – Qualitative), Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} 2014 17
Olive Oil Emulsion (Turbidimetric), Lipase Class 1 healgen 2010 1
Over-The-Counter Covid-19 Antigen Test Class 2 2026 5
Paper, Obstetric Ph Class 1 2021 13
Radioimmunoassay, Tricyclic Antidepressant Drugs Class 2 2015 9
Reagent, Coronavirus Serological Class N 2020 12
Reagent, Occult Blood Class 2 2011 5
Reagents, 2019-Novel Coronavirus Nucleic Acid Class N 2020 5
Real Time Nucleic Acid Amplification System Class 2 2020 15
Refractometer For Clinical Use Class 1 Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer, Healgen Scientific LLC Healgen 500 Urine Analyzer, Healgen Scientific LLC Healgen Reagent Strip for Urinalysis (Manual – Qualitative), Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} 2014 8
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings Class 2 2024 3
Test System, Nicotine, Cotinine, Metabolites Class 1 2019 11
Test, Amphetamine, Employment And Insurance Testing, Exempt Class 2 2019 11
Test, Amphetamine, Over The Counter Class 2 Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Urine Drug Screen Dip Card;, Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Accurate Multi-Drug Urine Screening Cup 2019 16
Test, Barbiturate, Employment And Insurance Testing, Exempt Class 2 2019 11
Test, Barbiturate, Over The Counter Class 2 Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Urine Drug Screen Dip Card;, Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Accurate Multi-Drug Urine Screening Cup 2019 16
Test, Benzodiazepine, Employment And Insurance Testing, Exempt Class 2 2019 11
Test, Benzodiazepine, Over The Counter Class 2 Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Urine Drug Screen Dip Card;, Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Accurate Multi-Drug Urine Screening Cup 2019 16
Test, Cannabinoid, Employment And Insurance Testing, Exempt Class 2 2019 12
Test, Cannabinoid, Over The Counter Class 2 Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Urine Drug Screen Dip Card;, Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Accurate Multi-Drug Urine Screening Cup 2019 16
Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt Class 2 2019 12
Test, Cocaine And Cocaine Metabolites, Over The Counter Class 2 Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Urine Drug Screen Dip Card;, Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Accurate Multi-Drug Urine Screening Cup 2019 16
Test, Codeine, Employment And Insurance Testing, Exempt Class 2 2019 4
Test, Follicle Stimulating Hormone (Fsh), Over The Counter Class 1 2025 30
Test, Luteinizing Hormone (Lh), Over The Counter Class 1 Healgen Scientific LLC., LH Luteinizing Hormone Test 2010 38
Test, Methadone, Employment And Insurance Testing, Exempt Class 2 2019 11
Test, Methadone, Over The Counter Class 2 Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Urine Drug Screen Dip Card;, Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Accurate Multi-Drug Urine Screening Cup 2019 17
Test, Methamphetamine, Employment And Insurance Testing, Exempt Class 2 2019 13
Test, Methamphetamine, Over The Counter Class 2 Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Urine Drug Screen Dip Card;, Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Accurate Multi-Drug Urine Screening Cup 2019 16
Test, Methaqualone, Employment And Insurance Testing, Exempt Class 2 2019 6
Test, Morphine, Employment And Insurance Testing, Exempt Class 2 2019 8
Test, Opiates, Employment And Insurance Testing, Exempt Class 2 2019 12
Test, Opiates, Over The Counter Class 2 Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Urine Drug Screen Dip Card;, Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Accurate Multi-Drug Urine Screening Cup, Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine), Healgen® Accurate Rapid Fentanyl Test Strip (Urine) and 4 more 2019 18
Test, Phencyclidine (Pcp), Over The Counter Class U Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Urine Drug Screen Dip Card;, Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Accurate Multi-Drug Urine Screening Cup 2019 12
Test, Propoxyphene, Employment And Insurance Testing, Exempt Class 2 2019 7
Test, Propoxyphene, Over The Counter Class 2 Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Urine Drug Screen Dip Card;, Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Accurate Multi-Drug Urine Screening Cup 2019 16
Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt Class 2 2019 7
Test, Tricyclic Antidepressants, Over The Counter Class 2 Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Urine Drug Screen Dip Card;, Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Accurate Multi-Drug Urine Screening Cup 2019 16
Test, Urine Leukocyte Class 1 Healgen Scientific LLC, URcheck URS Test Strip, Healgen Scientific LLC URcheck UTI Test Strip, Easy Healthcare Corporation easy@Home Urinary Tract Infection Test, Healgen Scientific LLC, Healgen URS Test Strip, Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer and 4 more 2014 16
Thin Layer Chromatography, Methamphetamine Class 2 2026 12
Turbidimetric Method, Lipoproteins Class 1 healgen 2010 1

Own-Brand Listings

Devices catalogued by Zhejiang Orient Gene Biotech
Product Code Catalogue numbers
Orient Gene LCX 6
Orient Gene KHE 2
One Step KHE 2

Clearances

No clearance names Zhejiang Orient Gene Biotech as applicant. 5 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Zhejiang Orient Gene Biotech or its listings
Clearance Decision date Product code Route Held by
K152269 2015-09-09 DKZ Traditional Healgen Scientific LLC
K151348 2015-08-18 LFG Traditional Healgen Scientific LLC
K150356 2015-05-13 JXM Special Healgen Scientific LLC
K110309 2011-09-14 KHE Traditional Orient Gene Biotech
K103574 2011-07-28 LCX Traditional Lehnus & Associates Consulting

From the Company

Published by the company on its own website, not by the FDA.

Information published by Zhejiang Orient Gene Biotech
Founded 2005
Main products infectious disease detection kits, drug testing products, PCR reagents, immunodiagnostic systems, liquid chip systems
Export markets US, Canada, 120+ countries and regions

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Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer