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Data / Medical devices / China / Zhejiang Orient Gene Biotech

Zhejiang Orient Gene Biotech: FDA-registered device maker in Huzhou Zhejiang, China, 5 510(k) clearances

Zhejiang Orient Gene Biotech is registered with the FDA (registration 3008517993) in Huzhou Zhejiang, China. It lists 89 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 9, 2015. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Zhejiang Orient Gene Biotech
FDA registration number
3008517993
Address
3787 East Yangguang Avenue Dipu Street, Anji, Huzhou Zhejiang, China, 313300
Owner or operator
Zhejiang Orient Gene Biotech Co., Ltd (10033347)
Roles
Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed
August 5, 2010
Registered through
2027
Brand names listed
Budpak Inc. Budpak Morphine Test Cassette, Budpak Inc. Budpak Morphine Test DipCard, Budpak Inc. Budpak Morphine Test Strip, Easy Healthcare Corporation  easy@Home Urinary Tract Infection Test, External Controls – Healgen Rapid Check COVID-19/Flu A&B Antigen Test Pro, External Controls – Second Generation FOB Rapid Test Cassette, HEALGEN SCIENTIFIC LLC Healgen MDMA (Ecstasy) Test Cassette, HEALGEN SCIENTIFIC LLC Healgen MDMA (Ecstasy) Test Cup and more

Devices it lists

DeviceProduct codeClassRoleSource
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)JMA1Contract manufactureraccessdata.fda.gov
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme MethodDIC2Contract manufactureraccessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Analyzer, Enzyme, For Clinical UseJJI1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Antigen, Cf (Including Cf Controls), Respiratory Syncytial VirusGQG1Contract manufactureraccessdata.fda.gov
Antigens, All Groups, Streptococcus Spp.GTY1Contract manufactureraccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Repackager or relabeleraccessdata.fda.gov
Automated Urinalysis SystemKQO1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)JJB1Contract manufactureraccessdata.fda.gov
Biuret (Colorimetric), Total ProteinCEK2Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Blood, Occult, Colorimetric, In UrineJIO2Contract manufactureraccessdata.fda.gov
Clinical Sample ConcentratorJJH1Contract manufactureraccessdata.fda.gov
Colorimeter, Photometer, Spectrophotometer For Clinical UseJJQ1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Colorimetric Method, TriglyceridesJGY1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Container, Specimen, SterileFMH1Manufactureraccessdata.fda.gov
Control, Fecal Occult BloodOSL2Complaint file establishment, Manufactureraccessdata.fda.gov
Coronavirus Antigen Detection Test System.QKPNContract manufactureraccessdata.fda.gov
Covid-19 Multi-Analyte Antigen DeviceQMNNContract manufactureraccessdata.fda.gov
Densitometeric, Protein FractionationJQJ1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Device, Fertility Diagnostic, ProceptiveLHDUContract manufactureraccessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)JMT1Contract manufacturer, Manufactureraccessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)CDM1Contract manufactureraccessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)CEN1Contract manufactureraccessdata.fda.gov
Enzymatic (Glutathione Reductase), GlutathioneJLO1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Enzymatic Esterase--Oxidase, CholesterolCHH1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, AmphetamineDKZ2Contract manufacturer, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, BarbiturateDIS2Contract manufactureraccessdata.fda.gov
Enzyme Immunoassay, BenzodiazepineJXM2Contract manufacturer, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, CannabinoidsLDJ2Contract manufacturer, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine MetabolitesDIO2Contract manufacturer, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, MethadoneDJR2Contract manufacturer, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, Nicotine And Nicotine MetabolitesMKU1Contract manufactureraccessdata.fda.gov
Enzyme Immunoassay, OpiatesDJG2Contract manufacturer, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMUContract manufactureraccessdata.fda.gov
Enzyme Immunoassay, PropoxypheneJXN2Contract manufacturer, Manufactureraccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
FluorometerJZT1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Gas Chromatography, MethamphetamineLAF2Contract manufacturer, Manufactureraccessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)JIR1Contract manufactureraccessdata.fda.gov
Kinetic Method, Gamma-Glutamyl TranspeptidaseJQB1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Kit, Direct Antigen, Negative ControlMKA1Contract manufactureraccessdata.fda.gov
Kit, Direct Antigen, Positive ControlMJZ1Contract manufactureraccessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The CounterLCX2Contract manufacturer, Manufactureraccessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)JIL2Contract manufactureraccessdata.fda.gov
Multi-Analyte Respiratory Virus Antigen Detection TestSCA2Contract manufactureraccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/SgptCKA1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
NephelometerJZW1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Nephelometer, For Clinical UseJQX1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1Contract manufacturer, Manufactureraccessdata.fda.gov
Olive Oil Emulsion (Turbidimetric), LipaseCET1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Over-The-Counter Covid-19 Antigen TestQYT2Contract manufactureraccessdata.fda.gov
Paper, Obstetric PhLNW1Contract manufactureraccessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant DrugsLFG2Contract manufacturer, Manufactureraccessdata.fda.gov
Reagent, Coronavirus SerologicalQKONContract manufactureraccessdata.fda.gov
Reagent, Occult BloodKHE2Contract manufacturer, Manufactureraccessdata.fda.gov
Reagents, 2019-Novel Coronavirus Nucleic AcidQJRNContract manufactureraccessdata.fda.gov
Real Time Nucleic Acid Amplification SystemOOI2Contract manufactureraccessdata.fda.gov
Refractometer For Clinical UseJRE1Contract manufactureraccessdata.fda.gov
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient SettingsQVF2Contract manufactureraccessdata.fda.gov
Test System, Nicotine, Cotinine, MetabolitesMRS1Contract manufactureraccessdata.fda.gov
Test, Amphetamine, Employment And Insurance Testing, ExemptPUX2Contract manufactureraccessdata.fda.gov
Test, Amphetamine, Over The CounterNFT2Contract manufactureraccessdata.fda.gov
Test, Barbiturate, Employment And Insurance Testing, ExemptPUY2Contract manufactureraccessdata.fda.gov
Test, Barbiturate, Over The CounterPTH2Contract manufactureraccessdata.fda.gov
Test, Benzodiazepine, Employment And Insurance Testing, ExemptPUZ2Contract manufactureraccessdata.fda.gov
Test, Benzodiazepine, Over The CounterNFV2Contract manufactureraccessdata.fda.gov
Test, Cannabinoid, Employment And Insurance Testing, ExemptPVJ2Contract manufactureraccessdata.fda.gov
Test, Cannabinoid, Over The CounterNFW2Contract manufactureraccessdata.fda.gov
Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, ExemptPVA2Contract manufactureraccessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The CounterNFY2Contract manufactureraccessdata.fda.gov
Test, Codeine, Employment And Insurance Testing, ExemptPVB2Contract manufactureraccessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The CounterNGA1Contract manufactureraccessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The CounterNGE1Contract manufacturer, Manufactureraccessdata.fda.gov
Test, Methadone, Employment And Insurance Testing, ExemptPVE2Contract manufactureraccessdata.fda.gov
Test, Methadone, Over The CounterPTG2Contract manufactureraccessdata.fda.gov
Test, Methamphetamine, Employment And Insurance Testing, ExemptPVD2Contract manufactureraccessdata.fda.gov
Test, Methamphetamine, Over The CounterNGG2Contract manufactureraccessdata.fda.gov
Test, Methaqualone, Employment And Insurance Testing, ExemptPVF2Contract manufactureraccessdata.fda.gov
Test, Morphine, Employment And Insurance Testing, ExemptPVG2Contract manufactureraccessdata.fda.gov
Test, Opiates, Employment And Insurance Testing, ExemptPVH2Contract manufactureraccessdata.fda.gov
Test, Opiates, Over The CounterNGL2Contract manufactureraccessdata.fda.gov
Test, Phencyclidine (Pcp), Over The CounterNGMUContract manufactureraccessdata.fda.gov
Test, Propoxyphene, Employment And Insurance Testing, ExemptPVI2Contract manufactureraccessdata.fda.gov
Test, Propoxyphene, Over The CounterQBF2Contract manufactureraccessdata.fda.gov
Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, ExemptPVK2Contract manufactureraccessdata.fda.gov
Test, Tricyclic Antidepressants, Over The CounterQAW2Contract manufactureraccessdata.fda.gov
Test, Urine LeukocyteLJX1Contract manufacturer, Manufactureraccessdata.fda.gov
Thin Layer Chromatography, MethamphetamineDJC2Contract manufactureraccessdata.fda.gov
Turbidimetric Method, LipoproteinsJHN1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 9, 2015K152269Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)DKZSubstantially EquivalentHealgen Scientific,, LLCaccessdata.fda.gov
August 18, 2015K151348Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)LFGSubstantially EquivalentHealgen Scientific,, LLCaccessdata.fda.gov
May 13, 2015K150356Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXMSubstantially EquivalentHealgen Scientific,, LLCaccessdata.fda.gov
September 14, 2011K110309FOB ONE STEP RAPID TESTKHESubstantially EquivalentOrient Gene Biotechaccessdata.fda.gov
July 28, 2011K103574PREGNANCY ONE STEP RAPID TESTLCXSubstantially EquivalentLehnus & Associates Consultingaccessdata.fda.gov

Compare with other makers

Updated September 9, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.