FDA Registration
Active
🇨🇳 China
KETOGEN KETONE TEST STRIPS
Reg #: 3003741796
·
FEI: 3003741796
·
Expires 2025
Products
12
Proprietary Names
5
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- DIRUI INDUSTRIAL CO., LTD.
- Registration Number
- 3003741796
- FEI Number
- 3003741796
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 95 YUNHE ST., NEW & HIGH TECH, DEVELOPMENT ZONE
- City
- CHANGCHUN Jilin
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K040703
Owner / Operator
- Firm Name
- DIRUI INDUSTRIAL CO., LTD.
- Operator Number
- 9049667
- Address
- 95 YUNHE ST.,NEW & HIGH TECH., DEVELOPMENT ZONE
- City
- CHANGCHUN
- State
- Jilin
- Postal Code
- 130012
- Country
- CN
- Correspondent
- Christopher M Patterson
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln., Suite 200
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2007-11-23 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2007-11-23 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2007-11-23 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2007-11-23 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2007-11-23 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2007-11-23 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2007-11-23 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2007-11-23 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2007-11-23 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2007-11-23 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2007-11-23 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2007-11-23 |
Proprietary Names
KETOGEN KETONE TEST STRIPS
DIRUI MUILTIPLE REAGENT STRIPS
URISTIK H SERIES REAGENT STRIPS
URS 10 parameter strips
DIRUI URINE ANALYZER
Establishment Types
Manufacture Medical Device