FDA Registration
Active
🇺🇸 United States
51185 Menarini Glucofix Mio Premium
Reg #: 1219029
·
FEI: 1219029
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
2
Classifications
1
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
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 |
|---|---|---|---|---|---|
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2015-04-22 |
Proprietary Names
51185 Menarini Glucofix Mio Premium
Nova StatStrip Xpress Glucose and B-Ketone Meter
Nova StatStrip Glucose and B-Ketone Meter
Nova Pro Glucose and B-Ketone Meter
Nova Pro Glucose and B-Ketone Controls and Linearity Solutions
Nova Pro Glucose Test Strips
Nova Pro B-Ketone Test Strips
StatStrip B-Ketone Test Strips
Nova StatStrip Glucose and B-Ketone Controls and Linearity Solutions
51184 Menarini Glucofix Mio Premium
Nipro StatStrip XP3
Establishment Types
Manufacture Device in the United States for Export Only
Manufacture Medical Device for Another Party (Contract Manufacturer)