Nova Biomedical Corporation

Contract manufacturer · Billerica, MA

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

2007Product codes first listed, by year (tallest: 3)2026

FDA registration: 3011979858 (openFDA record; or search FDA's registration database)
FEI number: 3011979858
Registered for: FDA registration year 2026
Establishment types: Complaint file establishment; Manufacturer for export only; Manufacturer; Contract manufacturer; Remanufacturer
Owner or operator: NOVA BIOMEDICAL CORP. (FDA owner/operator no. 1219029)
Registered address: 165 Lexington Rd, Billerica, MA 01821
Contract listings: 14 device listings, 8 product codes, first listed Oct 19, 2007
Certification: Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product code	Device (FDA name)	Class	Category	Role	First listed
CGA	Glucose Oxidase, Glucose	Class II	Clinical chemistry	Contract manufacturing	Oct 19, 2007
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Class I	Clinical chemistry	Contract manufacturing	Nov 26, 2010
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Class I	Clinical chemistry	Contract manufacturing	Oct 19, 2007
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Class I	Clinical chemistry	Contract manufacturing	Jul 17, 2013
LFR	Glucose Dehydrogenase, Glucose	Class II	Clinical chemistry	Contract manufacturing	May 1, 2012
NBW	System, Test, Blood Glucose, Over The Counter	Class II	Clinical chemistry	Contract manufacturing	Oct 19, 2007
PTC	Uric Acid Test System For At Home Prescription Use	Class I	Clinical chemistry	Contract manufacturing	May 11, 2017
PZI	Prescription Use Blood Glucose Meter For Near-Patient Testing	Class II	Clinical chemistry	Contract manufacturing	Jan 15, 2015