FDA Registration
Active
🇰🇷 South Korea
Uriscan Optima + Uriscan 10ACR Strip
Reg #: 9710094
·
FEI: 3003347234
·
Expires 2025
Products
10
Proprietary Names
1
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- YD DIAGNOSTICS
- Registration Number
- 9710094
- FEI Number
- 3003347234
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 76, Seori-ro, Idong-eup, Cheoin-gu
- City
- Yongin-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K182038
Owner / Operator
- Firm Name
- YD DIAGNOSTICS
- Operator Number
- 9044716
- Address
- 76, Seori-ro, Idong-myeon, Cheoin-gu
- City
- Yongin-si
- State
- Gyeonggi
- Postal Code
- 17127
- Country
- KR
US Agent
- Business Name
- Biosys Laboratories, Inc.
- Contact Name
- Jerri Pih (Hoi) Jerri Hoi
- Address
- 526 Mission Street South Pasadena
- City
- S Pasadena
- State
- CA
- ZIP
- 91030
- Country
- US
- [email protected]
- Phone
- 626 4036565
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2019-11-25 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2019-11-25 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2019-11-25 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2019-11-25 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2019-11-25 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2019-11-25 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2019-11-25 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2019-11-25 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2019-11-25 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2019-11-25 |
Proprietary Names
Uriscan Optima + Uriscan 10ACR Strip
Establishment Types
Manufacture Medical Device