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NOVA BIOMEDICAL CORPORATION

Last updated September 17, 2026

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)

Page 12 of 13

Device	Model / Reference	Registries	Class	Status
Stat Profile Ultra Blood Gas Controls	K952477	FDA 510(k)	Class I	Active
Nova Max Blood Glucose Monitor System, 90001, 90002	K070255	FDA 510(k)	Class II	Active
Stat Profile Critical Care Xpress (ccx), Model 1+	K061830	FDA 510(k)	Class II	Active
Nova 16 Analyzer (modification Point Of Care Usage)	K963005	FDA 510(k)	Class II	Active
Nova Glucose Low/High Level Control Solutions	K041016	FDA 510(k)	Class I	Active
Stat Profile Prime Plus Analyzer System	K200403	FDA 510(k)	Class II	Active
Nova 4 Na/K/C1/Tco2/Li Analyzer	K915176	FDA 510(k)	Class II	Active
Stat Profile Phox Plus L Analyzer	K012058	FDA 510(k)	Class II	Active
Nova Primary Glucose Analyzer System	K203549	FDA 510(k)	Class II	Active
Stat Profile Phox Basic Analyzer	K013729	FDA 510(k)	Class II	Active
Stat Profile Phox Plus C Analyzer	K021713	FDA 510(k)	Class II	Active
Module: Nova Nucleus Tmg Module Fluid Pack	K912321	FDA 510(k)	Class I	Active
Nova Max Mini Blood Glucose And B-Ketone Monitor	K122688	FDA 510(k)	Class II	Active
Nova 13 Analyzer, Modification	K924864	FDA 510(k)	Class II	Active
Statstrip Glucose Hospital Meter System	K132121	FDA 510(k)	Class II	Active
Nova Max Plus Blood Glucose And B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max Blood Glucos	K091547	FDA 510(k)	Class II	Active
Nova 13 Sodium/Potassium/Chloride/Lithium Analyzer	K872190	FDA 510(k)	Class II	Active
Nova Allegro HbA1c Assay, Nova Allegro Analyzer	K221326	FDA 510(k)	Class II	Active
Nova 12 Analyzer	K912560	FDA 510(k)	Class II	Active
Nova Stat Profile 5 Analyzer + Quality Control	K874832	FDA 510(k)	Class II	Active
Stat Profile Prime Plus Analyzer System	K193246	FDA 510(k)	Class II	Active
Nova Na/K/Cl/Li Module	K922943	FDA 510(k)	Class II	Active
Stat Profile Phox Plus Analyzer	K000895	FDA 510(k)	Class II	Active
StatStrip Glucose Hospital Meter	K150281	FDA 510(k)	Class II	Active
Stat Profile Critical Care Xpress Analyzer	K020297	FDA 510(k)	Class II	Active
Nova 16 Analyzer	K945584	FDA 510(k)	Class I	Active
Stat Profile Prime Plus Analyzer System	K200204	FDA 510(k)	Class II	Active
Stat Profile Prime Plus Analyzer System	K180340	FDA 510(k)	Class II	Active
StatStrip Xpress Blood Glucose Monitoring System	K170464	FDA 510(k)	Class II	Active
Stat Profile Prime Plus Analyzer System	K200349	FDA 510(k)	Class II	Active
Stat Profile Plus 9 Analyzer	K936066	FDA 510(k)	Class I	Active
Nova 3+3 Chloride/Total Carbon Dioxide	K792254	FDA 510(k)	Class II	Active
Calibrators, Control Materials, Electrodes & Tube	K897177	FDA 510(k)	Class II	Active
Analyzer, Sodium/Potassium Nova L	K770601	FDA 510(k)	Class II	Active
Stat Profile Prime Plus Analyzer System	K180186	FDA 510(k)	Class II	Active
Analyzer: Nova 10 Crt Analyzer & Quali Cont Mater	K923806	FDA 510(k)	Class II	Active
Stat Profile Ultra M Analyzer	K970710	FDA 510(k)	Class II	Active
Nova Allegro UACR Assay, Nova Allegro Analyzer	K252206	FDA 510(k)	Class II	Active
Stat Profile Prime ABG Analyzer System	K151982	FDA 510(k)	Class II	Active
Stat Profile 4 Analyzer + Quality Control Material	K864445	FDA 510(k)	Class II	Active
Stat Profile Ultra F, G, H, I, J, And K Analyzers	K960120	FDA 510(k)	Class II	Active
Stat Profile Prime ES Comp Plus Analyzer System	K191365	FDA 510(k)	Class II	Active
Nova Chemistry Linearity Set F, Levels 1, 2, 3, And 4	K955252	FDA 510(k)	Class I	Active
StatStrip Glucose Hospital Meter System	K181043	FDA 510(k)	Class II	Active
StatStrip Xpress 2 Glucose Hospital Meter System	K152986	FDA 510(k)	Class II	Active
Analyzer: Nova Stat Profile 3 Analyzer	K871397	FDA 510(k)	Class II	Active
StatStrip Glucose Hospital Meter System	K232075	FDA 510(k)	Class II	Active
Nova 8 Ionized Calcium/Ph Analyzer	K830502	FDA 510(k)	Class II	Active
StatStrip Xpress 2 Glucose Hospital Meter System	K163490	FDA 510(k)	Class II	Active
Stat Profile Ultra F, G, H, I, J, K, And L Analyzers	K981426	FDA 510(k)	Class II	Active

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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.

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