Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1219029

FEI Number

1219029

Entity Name

NOVA BIOMEDICAL CORPORATION

City/State/Country

WALTHAM, MA, US

Establishment Address

200 Prospect St, WALTHAM, MA 02454, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NOVA BIOMEDICAL CORP. (Owner Number: 1219029)

Owner / Operator Contact Address

200 PROSPECT ST., --, Waltham, MA 02454, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K982277

PMA Number

N/A

All Registered Proprietary Names

Stat Profile Prime Nova Chemistry Controls Dimension QuikLYTE Integrated Mutisensor Standard B Dimension QuikLYTE Integrated Multisensor Standard A Nova Stat Profile pHOx Basic Stat Profile pHOx Plus L INTERCEPT Blood System for Platelets Stat Profile Prime Plus Stat Profile Prime ABG Blood Gas Analyzer Nova Chemistry Controls StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter Stat Profile Prime ABG Analyzer Allegro UACR Controls Nova Stat Profile pHOx Plus StatStrip Xpress Nova 11 Nova 13 Nova 13 Nova Stat Profile pHOx Ultra Nova Stat Profile pHOx Plus Nova Stat Profile Critical Care Xpress Stat Profile Prime Plus Nova 12 Nova Stat Profile pHOx Nova Chemistry Linearity Nova Allegro System StatStrip Xpress Glucose Meter Nova StatStrip Nova StatStrip Xpress Nova 1 Nova Allegro System StatStrip Xpress 2 Glucose Hospital Meter Stat Profile Prime Plus Stat Profile Prime Plus Stat Profile Prime Plus INTERCEPT Blood System for Plasma Stat Profile Prime Plus Nova 14 Stat Profile Prime Plus StatStrip Glucose Hospital Meter System Nova Allegro HbA1c Assay Nova Allegro Analyzer Nova Stat Profile pHOx Stat Profile Prime CCS & CCS Comp Stat Profile Prime Plus Nova 16 Nova Allegro UCAR Assay Stat Profile Prime Plus Nova Max One Menarini Glucofix Mio Plus Nova Max Plus Menarini Glucofix Mio Menarini Glucomen Lx Menarini Glyco PC Nova Max Menarini Glucomen Lx 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 Nova Chemistry Performance Check Solution Stat Profile Prime Plus Nova StatStrip Nova Glucose Control Solutions Nova Glucose Control Solutions Nova 4 Nova Allegro System Stat Profile Prime Plus Nova StatProfile Critical Care Xpress Nova Stat Profile Critical Care Xpress Nova Allegro System StatSensor Nova Max Menarini GlycoPC Menarini Glucomen Lx Nova Stat Profile Critical Care Xpress Stat Profile Prime Plus Nova Allegro System Stat Profile Prime Plus Stat Profile Prime Plus Nova StatStrip Xpress Nova StatStrip Nova StatStrip Lactate Nova One Clot Catcher Sample Cup LifeScan OneTouch StatStrip StatStrip StatStrip Nova StatStrip Nova Stat Profile pHOx Plus C Nova 16 Nova 12 Nova Allegro System Nova Stat Profile pHOx

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2014-04-01
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2014-04-01
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2014-04-01
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2014-04-01
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-04-01
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2014-04-01
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2014-04-01
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2014-04-01
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2014-04-01
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-10-19
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2013-12-11
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-10-19
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2007-10-19
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2007-10-19
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2015-01-12
JKS	Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide	Clinical Toxicology	Class 1	862.3220	2015-01-12
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2015-01-12
JPI	Device, Hematocrit Measuring	Hematology	Class 2	864.6400	2015-01-12
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2015-01-12
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2015-01-12
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2015-01-12
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2015-01-12
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2015-01-12
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2015-01-12
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2015-01-12
PJF	Illuminator System For Blood Products	Unknown	Class 3	N/A	2015-01-05
JBJ	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduction	Hematology	Class 2	864.7360	2017-08-03
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2016-03-07
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-10-19
GIG	Hemoglobinometer	Hematology	Class 2	864.7500	2021-03-01
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
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2024-12-09
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2007-10-19
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-10-19
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2007-10-19
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2007-10-19
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2007-10-19
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2007-10-19
JPI	Device, Hematocrit Measuring	Hematology	Class 2	864.6400	2007-10-19
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2007-10-19
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2007-10-19
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-07-29
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-07-29
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-07-29
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2007-10-19
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2013-07-17
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-07-17
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2013-07-17
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2013-07-17
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2007-10-19
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2007-10-19
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
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2007-10-19
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2007-10-19
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2007-10-19
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2007-10-19
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	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	2007-10-19
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2007-10-19
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2007-10-19
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-10-19
GHS	Assay, Carboxyhemoglobin	Hematology	Class 2	864.7425	2007-10-19
CDS	Electrode, Ion Specific, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2007-10-19
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2007-10-19
CGL	Electrode, Ion Based, Enzymatic, Creatinine	Clinical Chemistry	Class 2	862.1225	2007-10-19
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2007-10-19
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2007-10-19
JKS	Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide	Clinical Toxicology	Class 1	862.3220	2007-10-19
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2007-10-19
CFA	Electrode, Ion Specific, Magnesium	Clinical Chemistry	Class 1	862.1495	2007-10-19
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2007-10-19
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-10-19
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2007-10-19
KRZ	Calibrator For Hemoglobin And Hematocrit Measurement	Hematology	Class 2	864.8165	2017-08-03
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2007-10-19
GLY	Oximeter To Measure Hemoglobin	Hematology	Class 2	864.7500	2007-10-19
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-10-19
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	Class 1	862.1475	2017-06-27
PZI	Prescription Use Blood Glucose Meter For Near-Patient Testing	Clinical Chemistry	Class 2	862.1345	2015-06-12
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2007-10-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-10-19
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2007-10-19
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2017-06-27
PZI	Prescription Use Blood Glucose Meter For Near-Patient Testing	Clinical Chemistry	Class 2	862.1345	2016-02-29
CDS	Electrode, Ion Specific, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2017-08-03
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
PJF	Illuminator System For Blood Products	Unknown	Class 3	N/A	2015-01-05
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
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2007-10-19
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2017-08-03
PZI	Prescription Use Blood Glucose Meter For Near-Patient Testing	Clinical Chemistry	Class 2	862.1345	2024-03-05
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2024-12-09
JQT	Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica	Clinical Chemistry	Class 1	862.2400	2024-12-09
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2007-10-19
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2007-10-19
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
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2017-08-03
JPI	Device, Hematocrit Measuring	Hematology	Class 2	864.6400	2007-10-19
JFL	Ph Rate Measurement, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2007-10-19
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2007-10-19
JJC	Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use	Clinical Chemistry	Class 1	862.2150	2007-10-19
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-10-19
CDS	Electrode, Ion Specific, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2007-10-19
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2007-10-19
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2007-10-19
CGL	Electrode, Ion Based, Enzymatic, Creatinine	Clinical Chemistry	Class 2	862.1225	2007-10-19
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2007-10-19
JIQ	Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2025-02-04
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2025-02-04
JQT	Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica	Clinical Chemistry	Class 1	862.2400	2025-02-04
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
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2010-11-26
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2017-08-03
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2015-06-22
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-10-19
JKS	Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide	Clinical Toxicology	Class 1	862.3220	2017-08-03
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2011-12-02
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-10-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-10-19
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2007-10-19
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2017-06-27
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2017-08-03
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2007-10-19
JGY	Colorimetric Method, Triglycerides	Clinical Chemistry	Class 1	862.1705	2017-06-27
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-10-19
CGL	Electrode, Ion Based, Enzymatic, Creatinine	Clinical Chemistry	Class 2	862.1225	2007-10-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-10-19
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2007-10-19
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2007-10-19
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2006-09-21
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2006-09-21
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2006-09-21
CGL	Electrode, Ion Based, Enzymatic, Creatinine	Clinical Chemistry	Class 2	862.1225	2017-08-03
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2017-06-27
GGZ	Oxyhemoglobin	Hematology	Class 2	864.7500	2017-08-03
GFS	Standards And Controls, Hemoglobin, Normal And Abnormal	Hematology	Class 2	864.8625	2017-08-03
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-05-01
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2012-05-01
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2013-07-17
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-07-17
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2013-07-17
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2022-11-29
PZI	Prescription Use Blood Glucose Meter For Near-Patient Testing	Clinical Chemistry	Class 2	862.1345	2015-06-12
PZI	Prescription Use Blood Glucose Meter For Near-Patient Testing	Clinical Chemistry	Class 2	862.1345	2015-01-15
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2007-10-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-10-19
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
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2018-02-12
JFL	Ph Rate Measurement, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2007-10-19
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2007-10-19
CGL	Electrode, Ion Based, Enzymatic, Creatinine	Clinical Chemistry	Class 2	862.1225	2007-10-19
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2007-10-19
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2007-10-19
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2017-06-27
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2007-10-19
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2007-10-19
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2007-10-19
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-10-19
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-10-19

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.

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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
3023162659	Nova Biomedical Corporation	Billerica, MA, US

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K840557	Shaban Mfg. Co.	REAGENTS & STANDARDS IL 501 NA/K	1984-04-04
K801007	Instrumentation Laboratory CO	IL SYSTEM 502 NA/K ANALYZER	1980-05-14
K884771	Instrumentation Laboratory CO	IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY	1989-02-10
K760969	Instrumentation Laboratory CO	PH/BLOOD GAS SYSTEM	1977-01-12
K820744	Instrumentation Laboratory CO	IL MODEL 1301, PH BLOOD GAS SYSTEM	1982-04-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0148-2020	Siemens Healthcare Diagnostics, Inc.	2	Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
Z-0038-2008	Radiometer America Inc	2	Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers.
Z-0778-2007	Instrumentation Laboratory Co.	2	GEM Premier 4000 Laboratory Analyzer
Z-0845-03	Instrumentation Laboratory Co.	2	GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reagent Cartridge. Part No. 24330004 (300 Sample Size) For In-Vitro Diagnostic Use
Z-0846-03	Instrumentation Laboratory Co.	2	GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. Part No. 24345004 (450 Sample Size) For In-Vitro Diagnostic Use

Similar Registrations

Registration Number	Establishment Name	Location
3012817228	Epocal Inc	Ottawa Ontario, CA
3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH
9612296	Beckman Coulter Mishima K.K.	SUNTO-GUN Shizuoka, JP
3006198300	Diamond Diagnostics Inc.	Budapest, HU
9610529	ROCHE DIAGNOSTICS GMBH	PENZBERG Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1219029. Last updated year: 2026. Please use registration number 1219029 when referencing this establishment in official correspondence.