FDA Registration
Active
🇺🇸 United States
CLINITEK Novus Automated Urine Chemistry Analyzer
Reg #: 3009448641
·
FEI: 3009448641
·
Expires 2025
Products
12
Proprietary Names
3
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- Siemens Healthcare Diagnostics, Inc.
- Registration Number
- 3009448641
- FEI Number
- 3009448641
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 430 S Beiger St
- City
- Mishawaka
- State
- IN
- ZIP
- 46544
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140717
Owner / Operator
- Firm Name
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Operator Number
- 9096044
- Address
- Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
- City
- Tarrytown
- State
- NY
- Postal Code
- 10591
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2014-11-24 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2014-11-24 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2014-11-24 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2014-11-24 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2014-11-24 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2014-11-24 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2014-11-24 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2014-11-24 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2014-11-24 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2014-11-24 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2014-11-24 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2014-11-24 |
Proprietary Names
CLINITEK Novus Automated Urine Chemistry Analyzer
CLINITEK Novus 10 Urinalysis Cassette
CLINITEK Novus Calibration Kit
Establishment Types
Manufacture Medical Device