Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011979858

FEI Number

3011979858

Entity Name

Nova Biomedical Corporation

City/State/Country

Billerica, MA, US

Establishment Address

165 Lexington Rd, Billerica, MA 01821, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Complaint File Establishment per 21 CFR 820.198,Manufacture Device in the United States for Export Only,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

K160990

PMA Number

N/A

All Registered Proprietary Names

StatStrip Xpress Glucose Meter Nova Max Link Nova One Nova Max Menarini GlycoPC Menarini Glucomen Lx Nova StatStrip StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter Nova Max Plus StatStrip StatStrip Xpress Nova Allegro System Nova StatStrip Xpress Nova StatStrip Nova StatStrip Lactate StatSensor Nova Max Nova Max One Nova Max

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2018-02-12
PZI	Prescription Use Blood Glucose Meter For Near-Patient Testing	Clinical Chemistry	Class 2	862.1345	2015-06-12
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
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
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	2007-10-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-10-19
GLY	Oximeter To Measure Hemoglobin	Hematology	Class 2	864.7500	2021-02-25
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
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	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
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2017-06-27
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
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
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
PTC	Uric Acid Test System For At Home Prescription Use	Clinical Chemistry	Class 1	862.1775	2017-05-11

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
3004193489	NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS	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
K180186	Nova Biomedical Corporation	Stat Profile Prime Plus Analyzer System	2018-08-23
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
K811074	Reagents Applications, Inc.	GLUCOSE REAGENT-ENZYMATIC-COLOR 500	1981-04-29
K936212	Heraeus Kulzer, Inc.	GLUCOFILM TEST STRIPS	1994-05-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0044-06	Abbott Laboratories Medisense Products	2	Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0378-06	Instrumentation Laboratory Co.	2	GEM PREMIER 3000

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011979858. Last updated year: 2026. Please use registration number 3011979858 when referencing this establishment in official correspondence.