BIONOSTICS, INC.

Contract manufacturer · Devens, MA

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

FDA registration: 1220649 (openFDA record; or search FDA's registration database)
FEI number: 1220649
Registered for: FDA registration year 2026
Establishment types: Manufacturer; Contract manufacturer
Owner or operator: BIONOSTICS, INC. (FDA owner/operator no. 1220649)
Registered address: 7 JACKSON RD., Devens, MA 01434
Contract listings: 39 device listings, 23 product codes, first listed Oct 28, 2009
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
CEM	Electrode, Ion Specific, Potassium	Class II	Clinical chemistry	Contract manufacturing	Nov 8, 2011
CGA	Glucose Oxidase, Glucose	Class II	Clinical chemistry	Contract manufacturing	Nov 8, 2011
CGZ	Electrode, Ion-Specific, Chloride	Class II	Clinical chemistry	Contract manufacturing	Nov 8, 2011
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Class II	Clinical chemistry	Contract manufacturing	Nov 8, 2011
DIF	Drug Mixture Control Materials	Class I	Clinical toxicology	Contract manufacturing	Oct 28, 2009
GFS	Standards And Controls, Hemoglobin, Normal And Abnormal	Class II	Hematology	Contract manufacturing	Nov 8, 2011
GGN	Plasma, Coagulation Control	Class II	Hematology	Contract manufacturing	Jul 9, 2013
GHS	Assay, Carboxyhemoglobin	Class II	Hematology	Contract manufacturing	Nov 8, 2011
GKF	Instrument, Hematocrit, Automated	Class II	Hematology	Contract manufacturing	Nov 8, 2011
GKR	System, Hemoglobin, Automated	Class II	Hematology	Contract manufacturing	Nov 8, 2011
GLK	Control, Hematocrit	Class II	Hematology	Contract manufacturing	Oct 28, 2009
JFP	Electrode, Ion Specific, Calcium	Class II	Clinical chemistry	Contract manufacturing	Nov 8, 2011
JGS	Electrode, Ion Specific, Sodium	Class II	Clinical chemistry	Contract manufacturing	Nov 8, 2011
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Class I	Clinical chemistry	Contract manufacturing	Oct 25, 2011
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Class I	Clinical chemistry	Contract manufacturing	Oct 28, 2009
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Class I	Clinical chemistry	Contract manufacturing	Oct 28, 2009
JPA	System, Multipurpose For In Vitro Coagulation Studies	Class II	Hematology	Contract manufacturing	Dec 13, 2013
JQP	Calculator/Data Processing Module, For Clinical Use	Class I	Clinical chemistry	Contract manufacturing	Apr 22, 2013
KHP	Acid, Lactic, Enzymatic Method	Class I	Clinical chemistry	Contract manufacturing	Nov 8, 2011
KQG	Instrument, Coagulation	Class II	Hematology	Contract manufacturing	Dec 13, 2013
LFR	Glucose Dehydrogenase, Glucose	Class II	Clinical chemistry	Contract manufacturing	Nov 8, 2011
NBW	System, Test, Blood Glucose, Over The Counter	Class II	Clinical chemistry	Contract manufacturing	Nov 8, 2011
OND	Osmolality Of Tears	Class I	Clinical chemistry	Contract manufacturing	Nov 8, 2011