FDA Registration
Active
🇨🇳 China
ZHEJIANG ORIENT GENE BIOTECH
Reg #: 3008517993
·
FEI: 3008517993
·
Expires 2026
Products
86
Proprietary Names
82
Establishment Types
4
Classifications
86
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Registration Details
- Registration Name
- ZHEJIANG ORIENT GENE BIOTECH
- Registration Number
- 3008517993
- FEI Number
- 3008517993
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3787 East Yangguang Avenue, Dipu Street, Anji
- City
- Huzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K152269
Owner / Operator
- Firm Name
- Zhejiang Orient Gene Biotech Co., Ltd
- Operator Number
- 10033347
- Address
- 3787#, East Yangguang Avenue, Dipu Street Anji
- City
- Huzhou
- State
- Zhejiang
- Postal Code
- 313300
- Country
- CN
- Correspondent
- JIANQIU FANG
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2014-04-09 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2014-04-09 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2014-04-09 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2014-04-09 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2014-04-09 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2014-04-09 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2014-04-09 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2014-04-09 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2014-04-09 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2014-04-09 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2014-04-09 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2014-04-09 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2026-01-15 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2026-01-15 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2026-01-15 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2026-01-15 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2026-01-15 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2026-01-15 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2026-01-15 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2026-01-15 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2026-01-15 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2026-01-15 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2026-01-15 |
| Enzyme Immunoassay, Nicotine And Nicotine Metabolites | MKU | Class 1 | Clinical Toxicology | No | 2023-05-19 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2023-05-19 |
| Test, Amphetamine, Employment And Insurance Testing, Exempt | PUX | Class 2 | Clinical Toxicology | No | 2019-01-04 |
| Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | QVF | Class 2 | Microbiology | No | 2024-04-22 |
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 2010-08-05 |
| Reagent, Occult Blood | KHE | Class 2 | Hematology | No | 2020-02-27 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2015-09-18 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2015-09-18 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2015-09-18 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2025-06-03 |
| Nephelometer | JZW | Class 1 | Immunology | No | 2010-08-09 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2010-08-06 |
| Device, Fertility Diagnostic, Proceptive | LHD | Class U | Unknown | No | 2017-03-28 |
| Test, Methamphetamine, Employment And Insurance Testing, Exempt | PVD | Class 2 | Clinical Toxicology | No | 2019-01-04 |
| Multi-Analyte Respiratory Virus Antigen Detection Test | SCA | Class 2 | Microbiology | No | 2024-10-09 |
| Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt | PVA | Class 2 | Clinical Toxicology | No | 2019-01-04 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2013-12-27 |
| Kinetic Method, Gamma-Glutamyl Transpeptidase | JQB | Class 1 | Clinical Chemistry | No | 2010-08-05 |
| Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | GQG | Class 1 | Microbiology | No | 2023-08-23 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2020-07-28 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2020-08-07 |
| Analyzer, Enzyme, For Clinical Use | JJI | Class 1 | Clinical Chemistry | No | 2010-08-05 |
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2020-03-20 |
| Test System, Nicotine, Cotinine, Metabolites | MRS | Class 1 | Clinical Toxicology | No | 2019-01-04 |
| Enzymatic (Glutathione Reductase), Glutathione | JLO | Class 1 | Clinical Chemistry | No | 2010-08-05 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2020-02-27 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2015-01-13 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2015-01-13 |
| Test, Morphine, Employment And Insurance Testing, Exempt | PVG | Class 2 | Clinical Toxicology | No | 2019-01-04 |
| Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | DIC | Class 2 | Clinical Toxicology | No | 2020-10-20 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2021-04-30 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2010-08-06 |
| Over-The-Counter Covid-19 Antigen Test | QYT | Class 2 | Microbiology | No | 2026-04-22 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2010-08-05 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2010-08-12 |
| Test, Propoxyphene, Employment And Insurance Testing, Exempt | PVI | Class 2 | Clinical Toxicology | No | 2019-01-03 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2015-08-19 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2015-08-19 |
| Colorimetric Method, Triglycerides | JGY | Class 1 | Clinical Chemistry | No | 2010-08-05 |
| Turbidimetric Method, Lipoproteins | JHN | Class 1 | Clinical Chemistry | No | 2010-08-05 |
| Olive Oil Emulsion (Turbidimetric), Lipase | CET | Class 1 | Clinical Chemistry | No | 2010-08-05 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2010-08-06 |
| Test, Methaqualone, Employment And Insurance Testing, Exempt | PVF | Class 2 | Clinical Toxicology | No | 2019-01-04 |
| Paper, Obstetric Ph | LNW | Class 1 | Clinical Chemistry | No | 2021-11-19 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2020-03-20 |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | PVJ | Class 2 | Clinical Toxicology | No | 2019-01-03 |
| Test, Codeine, Employment And Insurance Testing, Exempt | PVB | Class 2 | Clinical Toxicology | No | 2019-01-04 |
| Antigens, All Groups, Streptococcus Spp. | GTY | Class 1 | Microbiology | No | 2022-03-17 |
| Test, Benzodiazepine, Employment And Insurance Testing, Exempt | PUZ | Class 2 | Clinical Toxicology | No | 2019-01-04 |
| Test, Opiates, Employment And Insurance Testing, Exempt | PVH | Class 2 | Clinical Toxicology | No | 2019-01-03 |
| Nephelometer, For Clinical Use | JQX | Class 1 | Clinical Chemistry | No | 2010-08-09 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2017-10-17 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2017-10-17 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2026-04-28 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2019-06-18 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | Class 1 | Clinical Chemistry | No | 2010-08-05 |
| Test, Methadone, Employment And Insurance Testing, Exempt | PVE | Class 2 | Clinical Toxicology | No | 2019-01-04 |
| Control, Fecal Occult Blood | OSL | Class 2 | Hematology | No | 2026-06-09 |
| Covid-19 Multi-Analyte Antigen Device | QMN | Class N | Unknown | No | 2024-07-17 |
| Test, Barbiturate, Employment And Insurance Testing, Exempt | PUY | Class 2 | Clinical Toxicology | No | 2019-01-04 |
| Fluorometer | JZT | Class 1 | Immunology | No | 2010-08-09 |
| Densitometeric, Protein Fractionation | JQJ | Class 1 | Clinical Chemistry | No | 2010-08-05 |
| Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt | PVK | Class 2 | Clinical Toxicology | No | 2019-01-03 |
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 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 Scientific LLC. Rapid Check RSV Antigen Test Cassette
Healgen Scientific LLC Rapid Check RSV Antigen Test (Nasopharyngeal swabs)
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 Scientific LLC Healgen Multi-Drug Urine Test Dip Card
Healgen Scientific LLC Healgen Multi-Drug Urine Test Cup
Healgen Scientific LLC., LH Luteinizing Hormone Test
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 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
Life2O Full Panel Liver Function Urinalysis Test
Healgen Scientific LLC Strep A Antigen Test
Healgen Scientific LLC Strep A Rapid Test Strip (Throat Swab)
Healgen Scientific LLC Healgen Methadone Test Cup
Healgen Scientific LLC Healgen Buprenorphine Test Cassette
Healgen Scientific LLC Healgen Methadone Test Cassette
Healgen Scientific LLC Healgen Secobarbital Test Cassette
Healgen Scientific LLC Healgen Buprenorphine Test Dip Card
Healgen Scientific LLC Healgen Secobarbital Test Strip
Healgen Scientific LLC Healgen Methadone Test Dip Card
Healgen Scientific LLC Healgen Buprenorphine Test Cup
Healgen Scientific LLC Healgen Methadone Test Strip
Healgen Scientific LLC Healgen Buprenorphine Test Strip
Healgen Scientific LLC Healgen Secobarbital Test Cup
Healgen Scientific LLC Healgen Secobarbital Test Dip Card
External Controls Second Generation FOB Rapid Test Cassette
Healgen COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)
Healgen Scientific LLC Healgen Multi-Drug Urine Test Dip Card
Healgen Scientific LLC Healgen Multi-Drug Urine Test Cup
Healgen Scientific LLC Accurate Urine DOA Rapid Test Dipcard
Healgen Scientific LLC, Healgen URS Test Strip
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 Accurate Multi-Drug Urine Screening Cup
Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup
Healgen® URS Test Strips
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198