FDA Registration
Active
🇺🇸 United States
Nova Biomedical Corporation
Reg #: 3023162659
·
FEI: 3023162659
·
Expires 2026
Products
39
Proprietary Names
35
Establishment Types
4
Classifications
39
Registration Details
- Registration Name
- Nova Biomedical Corporation
- Registration Number
- 3023162659
- FEI Number
- 3023162659
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4 Enterprise Road
- City
- Billerica
- State
- MA
- ZIP
- 01821
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191365
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 |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Urea Nitrogen | CDS | Class 2 | Clinical Chemistry | No | 2017-08-03 |
| Electrode, Ion Based, Enzymatic, Creatinine | CGL | Class 2 | Clinical Chemistry | No | 2017-08-03 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2019-12-12 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2019-12-12 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2019-12-12 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2019-12-12 |
| Device, Hematocrit Measuring | JPI | Class 2 | Hematology | No | 2018-11-20 |
| System, Hemoglobin, Automated | GKR | Class 2 | Hematology | No | 2018-11-20 |
| Assay, Carboxyhemoglobin | GHS | Class 2 | Hematology | No | 2018-11-20 |
| Cyanomethemoglobin | GKK | Class 2 | Hematology | No | 2018-11-20 |
| Oxyhemoglobin | GGZ | Class 2 | Hematology | No | 2018-11-20 |
| Mixture, Hematology Quality Control | JPK | Class 2 | Hematology | No | 2017-08-03 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2017-08-03 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2017-06-27 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2007-10-19 |
| Retainer, Matrix | JEP | Class 1 | Dental | No | 2007-10-19 |
| Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide | JKS | Class 1 | Clinical Toxicology | No | 2007-10-19 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2007-10-19 |
| Test, Lactic Acid, Over The Counter | NGD | Class 1 | Clinical Chemistry | No | 2011-12-02 |
| Assay, Sulfhemoglobin | GJC | Class 2 | Hematology | No | 2011-12-02 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2011-12-02 |
| Electrode, Ion Specific, Magnesium | CFA | Class 1 | Clinical Chemistry | No | 2011-12-02 |
| Calibrator, Pressure, Gas | BXX | Class 1 | Anesthesiology | No | 2011-12-02 |
| Oximeter To Measure Hemoglobin | GLY | 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 |
| Controls For Blood-Gases, (Assayed And Unassayed) | JJS | Class 1 | Clinical Chemistry | No | 2017-08-03 |
| Instrument, Hematocrit, Automated | GKF | Class 2 | Hematology | No | 2016-03-07 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2016-03-07 |
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2017-06-27 |
| Bilirubin (Total And Unbound) In The Neonate Test System | MQM | Class 1 | Clinical Chemistry | No | 2017-08-03 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2022-11-29 |
| Alkaline Picrate, Colorimetry, Creatinine | CGX | Class 2 | Clinical Chemistry | No | 2017-06-27 |
| Calibrator For Hemoglobin And Hematocrit Measurement | KRZ | Class 2 | Hematology | No | 2017-08-03 |
| Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduction | JBJ | Class 2 | Hematology | No | 2017-08-03 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2017-06-26 |
| Standards And Controls, Hemoglobin, Normal And Abnormal | GFS | Class 2 | Hematology | No | 2017-08-03 |
| Colorimetric Method, Triglycerides | JGY | Class 1 | Clinical Chemistry | No | 2017-06-27 |
| Assay, Fetal Hemoglobin | KQI | Class 2 | Hematology | No | 2017-08-03 |
| Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | JQT | Class 1 | Clinical Chemistry | No | 2024-12-09 |
Proprietary Names
Stat Profile Prime Plus
Stat Profile Prime ES Comp Plus Analyzer System
Nova Allegro System
Nova 14
Nova Stat Profile pHOx Plus C
Nova Stat Profile pHOx Ultra
Stat Profile Prime CCS & CCS Comp
Stat Profile Prime ABG Analyzer
Clot Catcher
Sample Cup
Nova Stat Profile Prime ES
53417 Remanufactured Prime ES Comp
53461 Prime Calibrator Cartridge ES Comp 500 Sample
52853 Prime ES Comp
53663 Remanufactured Prime ES Comp w/ Scanner
53653 Prime ES Comp w/ Scanner
53103 Prime Calibrator Cartridge ES Comp 100 Sample
53110 Prime Ampuled Control ES
53102 Prime Calibrator Cartridge ES Comp 300 Sample
42035 Prime Sensor Card ES Comp
53598 Prime Demo Auto QC Cartridge
53600 Prime Demo Calibrator Cartridge
56452 Prime ES Diluent Solution
53460 Prime Calibrator Cartridge ES Comp 400 Sample
54786 Prime Demo Sensor Card ES Comp
53362 Prime Calibrator Cartridge ES Comp 200 Sample
53462 Prime Calibrator Cartridge ES Comp 600 Sample
Nova Primary Glucose Analyzer System
Nova 10
Nova Stat Profile pHOx
Stat Profile Prime
Stat Profile Prime ABG Blood Gas Analyzer
Nova Stat Profile pHOx Basic
Nova Allegro HbA1c Assay
Nova Allegro Analyzer
Establishment Types
Manufacture Device in the United States for Export Only
Remanufacture Medical Device
Manufacture Medical Device
Repack or Relabel Medical Device