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NOVA BIOMEDICAL CORPORATION

Last updated September 17, 2026

What NOVA BIOMEDICAL CORPORATION makes

Nova Biomedical Corporation manufactures in vitro diagnostic (IVD) devices for point-of-care and clinical chemistry testing, including portable and semi-automated analysers for metabolic profiling, blood gas analysis, haemoximetry, electrolyte measurement, and glucose monitoring. Products range from single-channel analysers to multichannel systems, designed for use in emergency, critical care, and laboratory settings. Control and calibrator solutions for blood gas and electrolyte analysers are also part of the portfolio.

The company’s devices are classified under FDA’s Class I and Class II regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Products are intended for use in the United States and comply with applicable IVD regulations.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Nova Biomedical Corporation manufacture?

Nova Biomedical Corporation specializes in in vitro diagnostic (IVD) devices primarily used for point-of-care and clinical chemistry testing. Their portfolio includes portable and semi-automated analysers for metabolic profiling, blood gas analysis, haemoximetry, electrolyte measurement, and glucose monitoring. Examples include single-channel and multichannel analysers, as well as control and calibrator solutions for blood gas and electrolyte analysers. These devices are designed for use in emergency, critical care, and laboratory settings.

Where is Nova Biomedical Corporation based?

Nova Biomedical Corporation is based in the United States. The company develops and manufactures its IVD devices within this region, adhering to applicable regulatory standards for in vitro diagnostics.

Which regulatory registries list Nova Biomedical Corporation’s devices?

Nova Biomedical Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their authorised in vitro diagnostic products, including analysers, controls, and calibrators, ensuring transparency and compliance with regulatory requirements.

How are Nova Biomedical Corporation’s devices classified under FDA regulations?

Nova Biomedical Corporation’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require less regulatory oversight, while Class II devices involve moderate risk and typically require special controls to ensure safety and effectiveness. The classification depends on the specific device type and its intended use, such as blood gas analysers or glucose monitoring systems.

What is the primary purpose of Nova Biomedical Corporation’s analysers and related products?

The primary purpose of Nova Biomedical Corporation’s analysers and related products is to provide rapid, accurate diagnostic results at the point of care or in clinical settings. Their devices enable healthcare professionals to monitor critical patient metrics like blood gases, electrolytes, glucose levels, and metabolic profiles quickly, supporting timely clinical decision-making in emergency, critical care, and laboratory environments.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 200 Prospect St, WALTHAM, MA, 02454
Website: novabio.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)545-6682
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1219029
DUNS Number: 070617139

Catalogue (629)

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Device	Model / Reference	Registries	Class	Status
Nova	Nova	FDA UDI	Class I	Active
Stat Profile	phox Ultra/CCX	FDA UDI	Class II	Active
Stat Profile	Prime Plus	FDA UDI	Class II	Active
Stat Profile	phox basic	FDA UDI	Class II	Active
StatStrip/StatSensor	1.0	FDA UDI	Class II	Active
Nova	10	FDA UDI	Class II	Active
Stat Profile	PHOX ULTRA	FDA UDI	Class II	Active
Stat Profile	Prime ES	FDA UDI	Class II	Active
Stat Profile	ULTRA/CCX	FDA UDI	Class I	Active
Stat Profile	PHOX PLUS L	FDA UDI	Class II	Active
Nova	10	FDA UDI	Class II	Active
Stat Profile	CCX	FDA UDI	Class II	Active
Stat Profile	PRIME CCS	FDA UDI	Class I	Active
Nova Max	Link	FDA UDI	Class II	Active
Stat Profile	PHOX	FDA UDI	Class II	Active
Nova	1/5/11	FDA UDI	Class II	Active
Nova	10	FDA UDI	Class II	Active
Nova	1	FDA UDI	Class II	Active
Nova	12/14	FDA UDI	Class II	Active
StatSensor	Creatinine	FDA UDI	Class I	Active
Stat Profile	pHOx Ultra/CCX	FDA UDI	Class II	Active
Stat Profile	PHOX	FDA UDI	Class II	Active
Stat Profile	phox Ultra/CCX	FDA UDI	Class I	Active
Stat Profile	PHOX ULTRA CO OX	FDA UDI	Class II	Active
Stat Profile	PHOX/BASIC/PLUS/L/C	FDA UDI	Class II	Active
Stat Profile	Prime Plus	FDA UDI	Class II	Active
Stat Profile	ULTRA	FDA UDI	Class II	Active
Nova	SUREFLEX	FDA UDI	Class II	Active
StatSensor/StatStrip	1.75	FDA UDI	Class II	Active
Nova	16	FDA UDI	Class I	Active
Stat Profile	Prime ES Plus	FDA UDI	Class II	Active
Stat Profile	Prime Plus	FDA UDI	Class II	Active
Stat Profile	PHOX PLUS C	FDA UDI	Class II	Active
Nova	1/4/5/8/10/11/12/13/14	FDA UDI	Class II	Active
Stat Profile	Prime Plus	FDA UDI	Class II	Active
Stat Profile	Prime Plus	FDA UDI	Class II	Active
Stat Profile	PRIME ABG	FDA UDI	Class I	Active
Stat Profile	PHOX ULTRA	FDA UDI	Class II	Active
Stat Profile	Prime Plus	FDA UDI	Class II	Active
Stat Profile	PHOX	FDA UDI	Class II	Active
Stat Profile	CCX	FDA UDI	Class II	Active
Stat Profile	Prime CCS Comp	FDA UDI	Class II	Active
Nova Primary	Nova Primary Calibrator Cartridge 150 Sample	FDA UDI	Class II	Active
StatSensor/StatStrip	1.0	FDA UDI	Class I	Active
Stat Profile	PRIME CCS	FDA UDI	Class II	Active
Stat Profile	Prime ES Plus	FDA UDI	Class II	Active
Stat Profile	PRIME	FDA UDI	Class II	Active
StatSensor/StatStrip	1.0	FDA UDI	Class II	Active
StatSensor/StatStrip	1.0	FDA UDI	Class II	Active
Lactate Plus	Blood Lactate Measuring Meter	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (36)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Nova Biomedical Corporation has 36 recall records initiated between September 22, 2003, and November 20, 2024, with statuses including open, classified, and terminated. The recalls involve issues such as calibration failures in analyzers, potential battery failures due to physical damage, software bugs causing erroneous glucose and creatinine test results, incorrect pump assembly leading to inconsistent readings, and discrepancies in calculated ionized calcium and magnesium values. Reasons also include erroneous low glucose or creatinine readings, software scheduling conflicts, and false high glucose readings from test strips.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Nov 20, 2024	Z-0683-2025	—	open, classified	A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current test result to the DMS.
Nov 20, 2024	Z-0682-2025	—	open, classified	A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current test result to the DMS.
Nov 20, 2024	Z-0681-2025	—	open, classified	A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current glucose test result to the DMS. The risk of this software defect is erroneously high or low glucose results being documented in a patient's medical record, which may lead to incorrect treatment.
Sep 18, 2023	Z-0207-2024	—	open, classified	Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge installation that may not be identified by traditional Quality Control practices.
Sep 18, 2023	Z-0208-2024	—	open, classified	Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge installation that may not be identified by traditional Quality Control practices.
Jun 19, 2017	Z-2732-2017	—	terminated	Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator and result in the pending patient result being overwritten with the A-QC test results.
Oct 10, 2013	Z-0650-2014	—	terminated	Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage
Jul 15, 2013	Z-1899-2013	—	terminated	Reports of false abnormally high glucose readings from test strips
Jul 15, 2013	Z-1898-2013	—	terminated	Reports of false abnormally high glucose readings from test strips
Jul 15, 2013	Z-1900-2013	—	terminated	Reports of false abnormally high glucose readings from test strips
Jul 15, 2013	Z-1903-2013	—	terminated	Reports of false abnormally high glucose readings from test strips
Jul 15, 2013	Z-1905-2013	—	terminated	Reports of false abnormally high glucose readings from test strips
Jul 15, 2013	Z-1904-2013	—	terminated	Reports of false abnormally high glucose readings from test strips
Jul 15, 2013	Z-1901-2013	—	terminated	Reports of false abnormally high glucose readings from test strips
Jul 15, 2013	Z-1897-2013	—	terminated	Reports of false abnormally high glucose readings from test strips
Jul 15, 2013	Z-1902-2013	—	terminated	Reports of false abnormally high glucose readings from test strips
Jul 15, 2013	Z-1906-2013	—	terminated	Reports of false abnormally high glucose readings from test strips
Feb 25, 2013	Z-1154-2013	—	terminated	Glucose test strips reports no result message when tested
Feb 25, 2013	Z-1153-2013	—	terminated	Glucose test strips reports no result message when tested
Feb 12, 2010	Z-1783-2010	—	terminated	Glucose strips report low glucose results
Aug 11, 2008	Z-1328-2009	—	terminated	Erroneous, low creatinine results on CCX analyzer
Feb 21, 2008	Z-1472-2008	—	terminated	Lithium batteries may fail if the glucose or creatinine meters have been dropped.
Nov 2, 2007	Z-0725-2008	—	terminated	Incorrect Results - Creatinine results were lower than the laboratory reference method.
Nov 2, 2007	Z-0724-2008	—	terminated	Incorrect Results - Creatinine results were lower than the laboratory reference method.
Nov 2, 2007	Z-0726-2008	—	terminated	Incorrect Results - Creatinine results were lower than the laboratory reference method.
Sep 17, 2007	Z-0295-2008	—	terminated	Elevated Normalized Ionized Calcium (nCa) and Normalized Ionized Magnesium (nMg) calculated values on patient samples
Jan 27, 2006	Z-0578-06	—	terminated	Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs
Jan 27, 2006	Z-0576-06	—	terminated	Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs
Jan 27, 2006	Z-0577-06	—	terminated	Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs
Mar 30, 2004	Z-0827-04	—	terminated	Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems
Mar 30, 2004	Z-0830-04	—	terminated	Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems
Mar 30, 2004	Z-0826-04	—	terminated	Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems
Mar 30, 2004	Z-0828-04	—	terminated	Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems
Mar 30, 2004	Z-0829-04	—	terminated	Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems
Sep 22, 2003	Z-0060-04	—	terminated	Degradation of the magnesium sensor could result in low ionozed magnesium patient samples
Sep 22, 2003	Z-0061-04	—	terminated	Degradation of the magnesium sensor could result in low ionozed magnesium patient samples