Nova Biomedical Corporation

FDA Device Registration & Listing · Billerica, MA, US · Registration 3023162659

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3023162659
FEI Number
3023162659
Entity Name
Nova Biomedical Corporation
City/State/Country
Billerica, MA, US
Establishment Address
4 Enterprise Road, Billerica, MA 01821, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
NOVA BIOMEDICAL CORP. (Owner Number: 1219029)
Owner / Operator Contact Address
200 PROSPECT ST., --, Waltham, MA 02454, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Stat Profile Prime Plus Stat Profile Prime Plus Stat Profile Prime ES Comp Plus Analyzer System Nova Allegro System Nova 14 Stat Profile Prime Plus Stat Profile Prime Plus Stat Profile Prime Plus Nova Allegro System Nova Stat Profile pHOx Plus C Stat Profile Prime Plus Nova Stat Profile pHOx Ultra Stat Profile Prime Plus Stat Profile Prime Plus Stat Profile Prime Plus Stat Profile Prime CCS & CCS Comp Stat Profile Prime ABG Analyzer Stat Profile Prime Plus Nova Allegro System Stat Profile Prime Plus Stat Profile Prime Plus Stat Profile Prime Plus Clot Catcher Sample Cup Nova Allegro System Stat Profile Prime Plus Stat Profile Prime Plus 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 Stat Profile Prime Plus Stat Profile Prime Plus Stat Profile Prime Plus Nova Primary Glucose Analyzer System Nova 10 Stat Profile Prime Plus

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CDS Electrode, Ion Specific, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2017-08-03
CGL Electrode, Ion Based, Enzymatic, Creatinine Clinical Chemistry Class 2 862.1225 2017-08-03
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2019-12-12
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2019-12-12
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2019-12-12
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2019-12-12
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2017-06-27
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2007-10-19
JPI Device, Hematocrit Measuring Hematology Class 2 864.6400 2018-11-20
GKR System, Hemoglobin, Automated Hematology Class 2 864.5620 2018-11-20
GHS Assay, Carboxyhemoglobin Hematology Class 2 864.7425 2018-11-20
GKK Cyanomethemoglobin Hematology Class 2 864.7500 2018-11-20
GGZ Oxyhemoglobin Hematology Class 2 864.7500 2018-11-20
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2017-08-03
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2017-08-03
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2017-06-27
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2007-10-19
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2007-10-19
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2007-10-19
GKR System, Hemoglobin, Automated Hematology Class 2 864.5620 2007-10-19
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2007-10-19
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2007-10-19
JEP Retainer, Matrix Dental Class 1 872.4565 2007-10-19
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2007-10-19
JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide Clinical Toxicology Class 1 862.3220 2007-10-19
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2007-10-19
JPI Device, Hematocrit Measuring Hematology Class 2 864.6400 2007-10-19
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2017-08-03
NGD Test, Lactic Acid, Over The Counter Clinical Chemistry Class 1 862.1450 2011-12-02
CDS Electrode, Ion Specific, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2011-12-02
GKK Cyanomethemoglobin Hematology Class 2 864.7500 2011-12-02
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2011-12-02
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2011-12-02
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2011-12-02
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2011-12-02
GJC Assay, Sulfhemoglobin Hematology Class 2 864.7490 2011-12-02
JFP Electrode, Ion Specific, Calcium Clinical Chemistry Class 2 862.1145 2011-12-02
CFA Electrode, Ion Specific, Magnesium Clinical Chemistry Class 1 862.1495 2011-12-02
BXX Calibrator, Pressure, Gas Anesthesiology Class 1 868.2620 2011-12-02
GLY Oximeter To Measure Hemoglobin Hematology Class 2 864.7500 2011-12-02
GHS Assay, Carboxyhemoglobin Hematology Class 2 864.7425 2011-12-02
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1115 2011-12-02
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2011-12-02
CGL Electrode, Ion Based, Enzymatic, Creatinine Clinical Chemistry Class 2 862.1225 2011-12-02
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2011-12-02
GGZ Oxyhemoglobin Hematology Class 2 864.7500 2011-12-02
GGZ Oxyhemoglobin Hematology Class 2 864.7500 2017-08-03
GHS Assay, Carboxyhemoglobin Hematology Class 2 864.7425 2017-08-03
JJS Controls For Blood-Gases, (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-08-03
GKF Instrument, Hematocrit, Automated Hematology Class 2 864.5600 2016-03-07
JJS Controls For Blood-Gases, (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2016-03-07
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2016-03-07
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2016-03-07
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2016-03-07
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2016-03-07
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2016-03-07
JFP Electrode, Ion Specific, Calcium Clinical Chemistry Class 2 862.1145 2016-03-07
KHP Acid, Lactic, Enzymatic Method Clinical Chemistry Class 1 862.1450 2016-03-07
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2016-03-07
JJS Controls For Blood-Gases, (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2014-11-26
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2014-11-26
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2014-11-26
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2018-11-20
LBR Ldl & Vldl Precipitation, Hdl Clinical Chemistry Class 1 862.1475 2017-06-27
GKR System, Hemoglobin, Automated Hematology Class 2 864.5620 2017-08-03
MQM Bilirubin (Total And Unbound) In The Neonate Test System Clinical Chemistry Class 1 862.1113 2017-08-03
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2017-08-03
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2022-11-29
CGX Alkaline Picrate, Colorimetry, Creatinine Clinical Chemistry Class 2 862.1225 2017-06-27
CDS Electrode, Ion Specific, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2018-11-20
CGL Electrode, Ion Based, Enzymatic, Creatinine Clinical Chemistry Class 2 862.1225 2018-11-20
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2018-11-20
CFA Electrode, Ion Specific, Magnesium Clinical Chemistry Class 1 862.1495 2017-08-03
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2015-06-22
KRZ Calibrator For Hemoglobin And Hematocrit Measurement Hematology Class 2 864.8165 2017-08-03
JBJ Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduction Hematology Class 2 864.7360 2017-08-03
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2018-11-20
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2018-11-20
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2018-11-20
JFP Electrode, Ion Specific, Calcium Clinical Chemistry Class 2 862.1145 2018-11-20
CFA Electrode, Ion Specific, Magnesium Clinical Chemistry Class 1 862.1495 2018-11-20
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2022-11-08
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2007-10-19
JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide Clinical Toxicology Class 1 862.3220 2017-08-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NOVA BIOMEDICAL CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3011979858 Nova Biomedical Corporation Billerica, MA, US
3004193489 NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS Billerica, MA, US
1219029 NOVA BIOMEDICAL CORPORATION WALTHAM, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K180186 Nova Biomedical Corporation Stat Profile Prime Plus Analyzer System 2018-08-23
K872302 Ciba Corning Diagnostics Corp. MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER 1987-09-08
K811310 Chem-Elec, Inc. SODIUM/POTASSIUM REAGENT KITS 1981-07-10
K013373 Roche Diagnostics Corp. OMNI C ANALYZER 2001-11-02
K840557 Shaban Mfg. Co. REAGENTS & STANDARDS IL 501 NA/K 1984-04-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-06 Abbott Laboratories, Inc 1
ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024 Ortho-Clinical Diagnostics, Inc. 1
Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06 Beckman Coulter Inc 1
Synchron LX Systems Version 4.5 Operating Software
Z-0010-06 Abbott Laboratories, Inc 1
ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
Z-0010-2019 Radiometer America Inc 1
ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023162659. Last updated year: 2026. Please use registration number 3023162659 when referencing this establishment in official correspondence.
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