FDA Registration
Active
🇺🇸 United States
53598 Prime Demo Auto QC Cartridge
Reg #: 3023162659
·
FEI: 3023162659
·
Expires 2025
Products
1
Proprietary Names
17
Establishment Types
1
Classifications
1
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
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, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2015-06-22 |
Proprietary Names
53598 Prime Demo Auto QC Cartridge
53600 Prime Demo Calibrator Cartridge
53417 Remanufactured Prime ES Comp
42035 Prime Sensor Card ES Comp
53103 Prime Calibrator Cartridge ES Comp 100 Sample
53460 Prime Calibrator Cartridge ES Comp 400 Sample
56452 Prime ES Diluent Solution
52853 Prime ES Comp
54786 Prime Demo Sensor Card ES Comp
53362 Prime Calibrator Cartridge ES Comp 200 Sample
53462 Prime Calibrator Cartridge ES Comp 600 Sample
53102 Prime Calibrator Cartridge ES Comp 300 Sample
53653 Prime ES Comp w/ Scanner
53663 Remanufactured Prime ES Comp w/ Scanner
Nova Stat Profile Prime ES
53110 Prime Ampuled Control ES
53461 Prime Calibrator Cartridge ES Comp 500 Sample
Establishment Types
Manufacture Device in the United States for Export Only