FDA Registration
Active
🇨🇳 China
Healgen 11 Reagent Strips for Urinalysus
Reg #: 3008517993
·
FEI: 3008517993
·
Expires 2025
Products
12
Proprietary Names
1
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- ZHEJIANG ORIENT GENE BIOTECH
- Registration Number
- 3008517993
- FEI Number
- 3008517993
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3787 East Yangguang Avenue, Dipu Street, Anji
- City
- Huzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K111999
Owner / Operator
- Firm Name
- Zhejiang Orient Gene Biotech Co., Ltd
- Operator Number
- 10033347
- Address
- 679 East Yangguang Avenue
- City
- DIPU
- State
- Zhejiang
- Postal Code
- 313300
- Country
- CN
- Correspondent
- JIANQIU FANG
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2014-04-09 |
| 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 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2014-04-09 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2014-04-09 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | 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 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2014-04-09 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2014-04-09 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2014-04-09 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2014-04-09 |
Proprietary Names
Healgen 11 Reagent Strips for Urinalysus
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)