FDA Registration
Active
🇺🇸 United States
Stat Profile Prime ES Comp Plus Analyzer System
Reg #: 3023162659
·
FEI: 3023162659
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- Nova Biomedical Corporation
- Registration Number
- 3023162659
- FEI Number
- 3023162659
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4 Enterprise Road
- City
- Billerica
- State
- MA
- ZIP
- 01821
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191626
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, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2019-12-12 |
| Electrode, Ion Specific, Magnesium | CFA | Class 1 | Clinical Chemistry | No | 2019-12-12 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2019-12-12 |
| Instrument, Hematocrit, Automated | GKF | Class 2 | Hematology | No | 2019-12-12 |
Proprietary Names
Stat Profile Prime ES Comp Plus Analyzer System
Establishment Types
Remanufacture Medical Device
Manufacture Medical Device