FDA Registration
Active
🇬🇧 United Kingdom
Siemens Multistix 10SG Urinalysis Reagent Strips
Reg #: 3030446844
·
FEI: 3030446844
·
Expires 2025
Products
11
Proprietary Names
1
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- PLATINUM FOCUS GROUP LTD.
- Registration Number
- 3030446844
- FEI Number
- 3030446844
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit 5, 1000 North Circular Road
- City
- London London, City of
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K992257
Owner / Operator
- Firm Name
- Platinum Focus Group Ltd.
- Operator Number
- 10089900
- Address
- Unit 5, 1000 North Circular Road
- City
- London
- State
- London, City of
- Postal Code
- NW2 7JP
- Country
- GB
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2024-12-20 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2024-12-20 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2024-12-20 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2024-12-20 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2024-12-20 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2024-12-20 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2024-12-20 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2024-12-20 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2024-12-20 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2024-12-20 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2024-12-20 |
Proprietary Names
Siemens Multistix 10SG Urinalysis Reagent Strips
Establishment Types
Export Device to the United States But Perform No Other Operation on Device