NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS

FDA Device Registration & Listing · Billerica, MA, US · Registration 3004193489

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
3004193489
FEI Number
3004193489
Entity Name
NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS
City/State/Country
Billerica, MA, US
Establishment Address
39 Manning Rd, Billerica, MA 01821, US
Establishment Type(s)
Remanufacture Medical Device,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device for Another Party (Contract Manufacturer),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
N
Expiration Date (Year)
2026
510(k) Number
K070068
PMA Number
N/A

All Registered Proprietary Names

Nova Max Plus StatStrip Xpress Nova Max Nova Max One Nova StatStrip Xpress Nova StatStrip Nova StatStrip Lactate True Focus Pro Focus Pro Focus Nova Max Menarini GlycoPC Menarini Glucomen Lx Nova Pro B-Ketone Test Strips Nova StatStrip Xpress Glucose and B-Ketone Meter Nova Pro Glucose and B-Ketone Controls and Linearity Solutions 51184 Menarini Glucofix Mio Premium Nova StatStrip Glucose and B-Ketone Controls and Linearity Solutions StatStrip B-Ketone Test Strips Nova StatStrip Glucose and B-Ketone Meter Nipro StatStrip XP3 Nova Pro Glucose Test Strips Nova Pro Glucose and B-Ketone Meter 51185 Menarini Glucofix Mio Premium StatStrip Nova Allegro System StatStrip Xpress Glucose Meter Nova One StatStrip Glucose Hospital Meter System Nova StatStrip Xpress Nova Max Link StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter Nova StatStrip LifeScan OneTouch StatStrip StatStrip StatStrip Xpress 2 Glucose Hospital Meter Nova StatStrip Nova StatStrip Xpress Nova Max StatSensor

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2010-11-26
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2010-11-26
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2010-11-26
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2010-11-26
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
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2012-05-01
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2012-05-01
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-05-01
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 2013-10-28
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2013-10-28
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2013-10-28
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
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2015-04-22
PZI Prescription Use Blood Glucose Meter For Near-Patient Testing Clinical Chemistry Class 2 862.1345 2015-01-15
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2017-06-27
PZI Prescription Use Blood Glucose Meter For Near-Patient Testing Clinical Chemistry Class 2 862.1345 2015-06-12
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
PZI Prescription Use Blood Glucose Meter For Near-Patient Testing Clinical Chemistry Class 2 862.1345 2024-03-05
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2008-10-28
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2007-01-31
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2007-01-31
GIG Hemoglobinometer Hematology Class 2 864.7500 2021-03-01
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
PZI Prescription Use Blood Glucose Meter For Near-Patient Testing Clinical Chemistry Class 2 862.1345 2015-06-12
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
PZI Prescription Use Blood Glucose Meter For Near-Patient Testing Clinical Chemistry Class 2 862.1345 2016-02-29
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
PTC Uric Acid Test System For At Home Prescription Use Clinical Chemistry Class 1 862.1775 2017-05-11
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

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
3023162659 Nova Biomedical Corporation Billerica, MA, US
1219029 NOVA BIOMEDICAL CORPORATION WALTHAM, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K811074 Reagents Applications, Inc. GLUCOSE REAGENT-ENZYMATIC-COLOR 500 1981-04-29
K936212 Heraeus Kulzer, Inc. GLUCOFILM TEST STRIPS 1994-05-10
K150396 Apex BioTechnology Corp. Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips 2015-10-14
K150833 Andon Health Co, Ltd. iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System 2015-12-04
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0378-06 Instrumentation Laboratory Co. 2
GEM PREMIER 3000
Z-2165-2011 Instrumentation Laboratory Co. 2
Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus
Z-0004-2009 Lifescan Inc 2
One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06 Abbott Laboratories Medisense Products 2
FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06 Abbott Laboratories Medisense Products 2
Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004193489. Last updated year: 2026. Please use registration number 3004193489 when referencing this establishment in official correspondence.
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