FDA Registration
Active
🇺🇸 United States
Nova Stat Profile pHOx Ultra
Reg #: 1219029
·
FEI: 1219029
·
Expires 2025
Products
18
Proprietary Names
1
Establishment Types
2
Classifications
18
Registration Details
- Registration Name
- NOVA BIOMEDICAL CORPORATION
- Registration Number
- 1219029
- FEI Number
- 1219029
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 200 Prospect St
- City
- WALTHAM
- State
- MA
- ZIP
- 02454
- Country
- US
Regulatory Submissions
- 510(k) Number
- K110648
Owner / Operator
- Firm Name
- NOVA BIOMEDICAL CORP.
- Operator Number
- 1219029
- Address
- 200 PROSPECT ST., --
- City
- Waltham
- State
- MA
- Postal Code
- 02454
- Country
- US
- Correspondent
- John F McHale
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Urea Nitrogen | CDS | Class 2 | Clinical Chemistry | No | 2011-12-02 |
| Cyanomethemoglobin | GKK | Class 2 | Hematology | No | 2011-12-02 |
| Test, Lactic Acid, Over The Counter | NGD | Class 1 | Clinical Chemistry | No | 2011-12-02 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2011-12-02 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2011-12-02 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2011-12-02 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2011-12-02 |
| Oximeter To Measure Hemoglobin | GLY | Class 2 | Hematology | No | 2011-12-02 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2011-12-02 |
| Calibrator, Pressure, Gas | BXX | Class 1 | Anesthesiology | No | 2011-12-02 |
| Assay, Sulfhemoglobin | GJC | Class 2 | Hematology | No | 2011-12-02 |
| Electrode, Ion Based, Enzymatic, Creatinine | CGL | Class 2 | Clinical Chemistry | No | 2011-12-02 |
| Electrode, Ion Specific, Magnesium | CFA | Class 1 | Clinical Chemistry | No | 2011-12-02 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2011-12-02 |
| Assay, Carboxyhemoglobin | GHS | Class 2 | Hematology | No | 2011-12-02 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2011-12-02 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2011-12-02 |
| Oxyhemoglobin | GGZ | Class 2 | Hematology | No | 2011-12-02 |
Proprietary Names
Nova Stat Profile pHOx Ultra
Establishment Types
Remanufacture Medical Device
Manufacture Medical Device