FDA Registration
Active
🇺🇸 United States
Nova Biomedical Corporation
Reg #: 3011979858
·
FEI: 3011979858
·
Expires 2026
Products
13
Proprietary Names
33
Establishment Types
5
Classifications
13
Registration Details
- Registration Name
- Nova Biomedical Corporation
- Registration Number
- 3011979858
- FEI Number
- 3011979858
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 165 Lexington Rd
- City
- Billerica
- State
- MA
- ZIP
- 01821
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150461
Owner / Operator
- Firm Name
- NOVA BIOMEDICAL CORP.
- Operator Number
- 1219029
- Address
- 200 PROSPECT ST., --
- City
- Waltham
- State
- MA
- Postal Code
- 02454
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2018-02-12 |
| Prescription Use Blood Glucose Meter For Near-Patient Testing | PZI | Class 2 | Clinical Chemistry | No | 2015-06-12 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2007-01-31 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2007-01-31 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2013-07-17 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2013-07-17 |
| Oximeter To Measure Hemoglobin | GLY | Class 2 | Hematology | No | 2021-02-25 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2017-06-27 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2012-05-01 |
| Electrode, Ion Based, Enzymatic, Creatinine | CGL | Class 2 | Clinical Chemistry | No | 2007-10-19 |
| Uric Acid Test System For At Home Prescription Use | PTC | Class 1 | Clinical Chemistry | No | 2017-05-11 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2013-07-17 |
| Hemoglobinometer | GIG | Class 2 | Hematology | No | 2021-03-01 |
Proprietary Names
StatStrip Xpress Glucose Meter
Nova Max Link
Nova One
Nova Max
Menarini GlycoPC
Menarini Glucomen Lx
Nova StatStrip
StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter
Nova Max Plus
StatStrip
StatStrip Xpress
Nova Allegro System
Nova StatStrip Xpress
Nova StatStrip Lactate
StatSensor
Nova Max One
True Focus Pro
Focus Pro
Focus
StatStrip Xpress 2 Glucose Hospital Meter
Nova Pro B-Ketone Test Strips
Nova StatStrip Xpress Glucose and B-Ketone Meter
Nova Pro Glucose and B-Ketone Controls and Linearity Solutions
51184 Menarini Glucofix Mio Premium
Nova StatStrip Glucose and B-Ketone Controls and Linearity Solutions
StatStrip B-Ketone Test Strips
Nova StatStrip Glucose and B-Ketone Meter
Nipro StatStrip XP3
Nova Pro Glucose Test Strips
Nova Pro Glucose and B-Ketone Meter
51185 Menarini Glucofix Mio Premium
StatStrip Glucose Hospital Meter System
LifeScan OneTouch StatStrip
Establishment Types
Manufacture Device in the United States for Export Only
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device for Another Party (Contract Manufacturer)
Remanufacture Medical Device
Manufacture Medical Device