Bionostics Inc

FDA Filings

This page includes the latest FDA filings for Bionostics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1220649
• FEI Number: 1220649
• Name: BIONOSTICS, INC.
• Owner & Operator: BIONOSTICS, INC.
• Contact Address: 7 JACKSON RD. --; Devens MA 01434 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 7 JACKSON RD. ; Devens, MA 01434 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K170064 | NBW BIONOSTICS, INC.	Assure Control Control Solution	2019-06-10
PMN K113135 | NBW BIONOSTICS, INC.	UniStrip Glucose Control	2018-11-21
PMN K113135 | CGA BIONOSTICS, INC.	UniStrip Glucose Control	2018-11-21
PMN K062058 | NBW BIONOSTICS, INC.	Contour TS Controls	2017-01-25
PMN K062058 | LFR BIONOSTICS, INC.	Contour TS Controls	2017-01-25
FMH BIONOSTICS, INC.	Paratest	2016-11-18
PMN K141829 | NBW BIONOSTICS, INC.	JJX GlucoVitaal HbA1c Control	2015-01-05
PMN K141829 | LFR BIONOSTICS, INC.	JJX GlucoVitaal HbA1c Control	2015-01-05
PMN K141829 | JJX BIONOSTICS, INC.	JJX GlucoVitaal HbA1c Control	2015-01-05
PMN K124021 | NBW BIONOSTICS, INC.	ARKRAY GLUCOCARD glucose control solution	2015-01-05
PMN K124021 | CGA BIONOSTICS, INC.	ARKRAY GLUCOCARD glucose control solution	2015-01-05
PMN K123090 | NBW BIONOSTICS, INC.	JJX BeneCheck Glucose Control Solution	2015-01-05
PMN K123090 | JJX BIONOSTICS, INC.	JJX BeneCheck Glucose Control Solution	2015-01-05
PMN K123090 | CGA BIONOSTICS, INC.	JJX BeneCheck Glucose Control Solution	2015-01-05
PMN K120183 | NBW BIONOSTICS, INC.	JJX Advocate Glucose Control Solution	2015-01-05
PMN K120183 | JJX BIONOSTICS, INC.	JJX Advocate Glucose Control Solution	2015-01-05
PMN K120183 | CGA BIONOSTICS, INC.	JJX Advocate Glucose Control Solution	2015-01-05
PMN K913133 | JJY BIONOSTICS, INC.	RNA Medical CC527 Blood Gas, Electrolyte, CO-Oximeter Control	2014-04-16
PMN K092104 | NBW BIONOSTICS, INC.	ARKRAY Assure Dose Glucose Control Solution	2014-01-20
PMN K092104 | JJX BIONOSTICS, INC.	ARKRAY Assure Dose Glucose Control Solution	2014-01-20
PMN K092104 | CGA BIONOSTICS, INC.	ARKRAY Assure Dose Glucose Control Solution	2014-01-20
PMN K983475 | KQG BIONOSTICS, INC.	directCheck PRO Protime Control	2013-12-13
PMN K983475 | KQG BIONOSTICS, INC.	directCheck High Dose Thrombin Time (HiTT) Control	2013-12-13
PMN K983475 | KQG BIONOSTICS, INC.	HepCheck Whole Blood Control	2013-12-13
PMN K983475 | JPA BIONOSTICS, INC.	directCheck PRO Protime Control	2013-12-13
PMN K983475 | JPA BIONOSTICS, INC.	directCheck High Dose Thrombin Time (HiTT) Control	2013-12-13
PMN K983475 | JPA BIONOSTICS, INC.	HepCheck Whole Blood Control	2013-12-13
PMN K882481 | GGN BIONOSTICS, INC.	Hemochron Whole Blood ACT Control	2013-12-13
PMN K131136 | JJX BIONOSTICS, INC.	Glucose Meter-Check Solution for TaiDoc	2013-12-13
PMN K120989 | NBW BIONOSTICS, INC.	TRUEmetrix Glucose Control	2013-12-13
PMN K120989 | LFR BIONOSTICS, INC.	TRUEmetrix Glucose Control	2013-12-13
PMN K120989 | JJX BIONOSTICS, INC.	TRUEmetrix Glucose Control	2013-12-13
PMN K120977 | GGN BIONOSTICS, INC.	directCheck Whole Blood ACT-Low Range Control	2013-12-13
PMN K120977 | GGN BIONOSTICS, INC.	directCheck Whole Blood ACT+ Control	2013-12-13
PMN K120921 | NBW BIONOSTICS, INC.	Clever Choice Glucose Control	2013-12-13
PMN K120921 | JJX BIONOSTICS, INC.	Clever Choice Glucose Control	2013-12-13
PMN K120921 | CGA BIONOSTICS, INC.	Clever Choice Glucose Control	2013-12-13
PMN K113670 | NBW BIONOSTICS, INC.	Infopia Glucose Control	2013-12-13
PMN K113670 | JJX BIONOSTICS, INC.	Infopia Glucose Control	2013-12-13
PMN K113670 | CGA BIONOSTICS, INC.	Infopia Glucose Control	2013-12-13
PMN K113636 | NBW BIONOSTICS, INC.	GMate Voice Glucose Control	2013-12-13
PMN K113636 | JJX BIONOSTICS, INC.	GMate Voice Glucose Control	2013-12-13
PMN K113636 | CGA BIONOSTICS, INC.	GMate Voice Glucose Control	2013-12-13
PMN K020798 | JPA BIONOSTICS, INC.	directCheck Whole Blood PT Control	2013-12-13
PMN K020798 | JPA BIONOSTICS, INC.	directCheck Whole Blood Citrated PT/APTT Control	2013-12-13
PMN K020798 | JPA BIONOSTICS, INC.	directCheck Whole Blood Citrated PT Control	2013-12-13
PMN K020798 | JPA BIONOSTICS, INC.	directCheck Whole Blood APTT Control	2013-12-13
PMN K020798 | JPA BIONOSTICS, INC.	GEM Check PT Control	2013-12-13
PMN K020798 | JPA BIONOSTICS, INC.	GEM Check Citrated PT Control	2013-12-13
PMN K020798 | JPA BIONOSTICS, INC.	GEM Check APTT Control	2013-12-13
PMN K020798 | JPA BIONOSTICS, INC.	GEM Check ACT Low Range Control	2013-12-13
PMN K020798 | JPA BIONOSTICS, INC.	GEM Check ACT Control	2013-12-13
PMN K944691 | GGN BIONOSTICS, INC.	various ITC Direct Check Coagulation Controls, Normal and Abnormal	2013-07-09
PMN K131136 BIONOSTICS, INC.	GLUCOSE METER-CHECK SOLUTION FOR TAIDOC	2013-05-31
PMN K111456 | NBW BIONOSTICS, INC.	EMPECS Glucose Control	2013-04-22
PMN K111456 | JJX BIONOSTICS, INC.	EMPECS Glucose Control	2013-04-22
PMN K111456 | CGA BIONOSTICS, INC.	EMPECS Glucose Control	2013-04-22
PMN K103544 | NBW BIONOSTICS, INC.	iBGStar Glucose Control	2013-04-22
PMN K103544 | JQP BIONOSTICS, INC.	iBGStar Glucose Control	2013-04-22
PMN K103544 | JJX BIONOSTICS, INC.	iBGStar Glucose Control	2013-04-22
PMN K103544 | CGA BIONOSTICS, INC.	iBGStar Glucose Control	2013-04-22
PMN K073118 | NBW BIONOSTICS, INC.	Prodigy Glucose Control	2013-04-22
PMN K073118 | CGA BIONOSTICS, INC.	Prodigy Glucose Control	2013-04-22
PMN K123851 BIONOSTICS, INC.	GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK	2013-02-14
PMN K123966 BIONOSTICS, INC.	GLUCOSE METER-CHECK SOLUTION FOR BAYER	2013-01-25
PMN K090389 | NBW BIONOSTICS, INC.	JJX Major Glucose Control Solution	2012-12-21
PMN K090389 | JJX BIONOSTICS, INC.	JJX Major Glucose Control Solution	2012-12-21
PMN K090389 | CGA BIONOSTICS, INC.	JJX Major Glucose Control Solution	2012-12-21
PMN K121679 | NBW BIONOSTICS, INC.	ACCU-CHEK Inform II Linearity Test Kit	2012-10-31
PMN K121679 | NBW BIONOSTICS, INC.	ACCU-CHEK Inform II Controls	2012-10-31
PMN K121679 | LFR BIONOSTICS, INC.	ACCU-CHEK Inform II Linearity Test Kit	2012-10-31
PMN K121679 | LFR BIONOSTICS, INC.	ACCU-CHEK Inform II Controls	2012-10-31
PMN K121679 | JJX BIONOSTICS, INC.	ACCU-CHEK Inform II Linearity Test Kit	2012-10-31
PMN K121679 | JJX BIONOSTICS, INC.	ACCU-CHEK Inform II Controls	2012-10-31
PMN K113764 | JJX BIONOSTICS, INC.	Glucose Meter-Check Solution for Infopia	2012-05-24
PMN K091914 | JJX BIONOSTICS, INC.	Glucose Meter-Check Solution for OMNIS Health	2012-05-24
PMN K112352 | JJX BIONOSTICS, INC.	Glucose Meter-Check Solution for NIPRO	2012-05-23
PMN K113764 BIONOSTICS, INC.	GLUCOSE METER-CHECK SOLUTION FOR INFOPIA	2012-01-30
PMN K112352 BIONOSTICS, INC.	GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT	2011-12-23
PMN K093941 | NBW BIONOSTICS, INC.	JJX Clever Choice Glucose Control	2011-11-09
PMN K093941 | CGA BIONOSTICS, INC.	JJX Clever Choice Glucose Control	2011-11-09
PMN K081714 | NBW BIONOSTICS, INC.	JJX FORA Glucose Control	2011-11-09
PMN K081714 | DXN BIONOSTICS, INC.	JJX FORA Glucose Control	2011-11-09
PMN K081714 | CGA BIONOSTICS, INC.	JJX FORA Glucose Control	2011-11-09
PMN K072039 | NBW BIONOSTICS, INC.	JJX Advocate Glucose Control	2011-11-09
PMN K072039 | CGA BIONOSTICS, INC.	JJX Advocate Glucose Control	2011-11-09
PMN K062235 | NBW BIONOSTICS, INC.	JJX Easy Check Glucose Control	2011-11-09
PMN K062235 | CGA BIONOSTICS, INC.	JJX Easy Check Glucose Control	2011-11-09
PMN K051514 | NBW BIONOSTICS, INC.	JJX Arkray Assure Dose Glucose Control	2011-11-09
PMN K051514 | CGA BIONOSTICS, INC.	JJX Arkray Assure Dose Glucose Control	2011-11-09
PMN K042005 | NBW BIONOSTICS, INC.	Clever Check Glucose Control	2011-11-09
PMN K042005 | CGA BIONOSTICS, INC.	Clever Check Glucose Control	2011-11-09
PMN K040796 | NBW BIONOSTICS, INC.	Roche ACCU-CHEK GO Glucose Control Solution	2011-11-09
PMN K040796 | LFR BIONOSTICS, INC.	Roche ACCU-CHEK GO Glucose Control Solution	2011-11-09
PMN K004010 | LFR BIONOSTICS, INC.	JJX Roche Accu-Chek Compact Glucose Control	2011-11-09
PMN K984261 | CGA BIONOSTICS, INC.	JJX LifeScan SureStep Glucose Control Solution	2011-11-08
PMN K982303 | CGA BIONOSTICS, INC.	JJX ADC Precision Glucose Control	2011-11-08
PMN K970556 | CGA BIONOSTICS, INC.	JJX LifeScan OneTouch SureStep Pro Glucose Control Solution	2011-11-08
PMN K934907 | CHL BIONOSTICS, INC.	JJX Siemens RapidLab High Glucose Control	2011-11-08
PMN K093745 | NBW BIONOSTICS, INC.	JJX LifeScan OneTouch Verio Glucose Control Solution	2011-11-08
PMN K093745 | LFR BIONOSTICS, INC.	JJX LifeScan OneTouch Verio Glucose Control Solution	2011-11-08
PMN K093745 | JJX BIONOSTICS, INC.	JJX LifeScan OneTouch Verio Glucose Control Solution	2011-11-08
PMN K093262 | NBW BIONOSTICS, INC.	JJX ANDON Health Glucose Control	2011-11-08
PMN K093262 | JJX BIONOSTICS, INC.	JJX ANDON Health Glucose Control	2011-11-08
PMN K093262 | CGA BIONOSTICS, INC.	JJX ANDON Health Glucose Control	2011-11-08
PMN K091711 | LCP BIONOSTICS, INC.	Calibrator Glycosylated Hemoglobin	2011-11-08
PMN K083184 | OND BIONOSTICS, INC.	JJX TearLab Osmolarity Control	2011-11-08
PMN K083184 | JJX BIONOSTICS, INC.	JJX TearLab Osmolarity Control	2011-11-08
PMN K080641 | NBW BIONOSTICS, INC.	JJX NIPRO TRUEtest Solution	2011-11-08
PMN K080641 | LFR BIONOSTICS, INC.	JJX NIPRO TRUEtest Solution	2011-11-08
PMN K070585 | NBW BIONOSTICS, INC.	JJX Roche AccuCheck Performa Glucose Control Solution	2011-11-08
PMN K070585 | LFR BIONOSTICS, INC.	JJX Roche AccuCheck Performa Glucose Control Solution	2011-11-08
PMN K070524 | NBW BIONOSTICS, INC.	Cambridge Sensors microDot Glucose Control	2011-11-08
PMN K070524 | LFR BIONOSTICS, INC.	Cambridge Sensors microDot Glucose Control	2011-11-08
PMN K070524 | JJX BIONOSTICS, INC.	Cambridge Sensors microDot Glucose Control	2011-11-08
PMN K062347 | NBW BIONOSTICS, INC.	JJX Breeze 2 Glucose Control Solution	2011-11-08
PMN K062347 | JJX BIONOSTICS, INC.	JJX Breeze 2 Glucose Control Solution	2011-11-08
PMN K062347 | CGA BIONOSTICS, INC.	JJX Breeze 2 Glucose Control Solution	2011-11-08
PMN K061974 | KHP BIONOSTICS, INC.	JJY Instrumentation Lab GEM Creatine Control	2011-11-08
PMN K061974 | KHP BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit PVP Kit	2011-11-08
PMN K061974 | KHP BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit Check	2011-11-08
PMN K061974 | JJY BIONOSTICS, INC.	JJY Instrumentation Lab GEM Creatine Control	2011-11-08
PMN K061974 | JJY BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit PVP Kit	2011-11-08
PMN K061974 | JJY BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit Check	2011-11-08
PMN K061974 | JGS BIONOSTICS, INC.	JJY Instrumentation Lab GEM Creatine Control	2011-11-08
PMN K061974 | JGS BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit PVP Kit	2011-11-08
PMN K061974 | JGS BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit Check	2011-11-08
PMN K061974 | JFP BIONOSTICS, INC.	JJY Instrumentation Lab GEM Creatine Control	2011-11-08
PMN K061974 | JFP BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit PVP Kit	2011-11-08
PMN K061974 | JFP BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit Check	2011-11-08
PMN K061974 | GLK BIONOSTICS, INC.	JJY Instrumentation Lab GEM Creatine Control	2011-11-08
PMN K061974 | GLK BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit PVP Kit	2011-11-08
PMN K061974 | GLK BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit Check	2011-11-08
PMN K061974 | GKR BIONOSTICS, INC.	JJY Instrumentation Lab GEM Creatine Control	2011-11-08
PMN K061974 | GKR BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit PVP Kit	2011-11-08
PMN K061974 | GKR BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit Check	2011-11-08
PMN K061974 | GKF BIONOSTICS, INC.	JJY Instrumentation Lab GEM Creatine Control	2011-11-08
PMN K061974 | GKF BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit PVP Kit	2011-11-08
PMN K061974 | GKF BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit Check	2011-11-08
PMN K061974 | GHS BIONOSTICS, INC.	JJY Instrumentation Lab GEM Creatine Control	2011-11-08
PMN K061974 | GHS BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit PVP Kit	2011-11-08
PMN K061974 | GHS BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit Check	2011-11-08
PMN K061974 | CHL BIONOSTICS, INC.	JJY Instrumentation Lab GEM Creatine Control	2011-11-08
PMN K061974 | CHL BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit PVP Kit	2011-11-08
PMN K061974 | CHL BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit Check	2011-11-08
PMN K061974 | CGZ BIONOSTICS, INC.	JJY Instrumentation Lab GEM Creatine Control	2011-11-08
PMN K061974 | CGZ BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit PVP Kit	2011-11-08
PMN K061974 | CGZ BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit Check	2011-11-08
PMN K061974 | CGA BIONOSTICS, INC.	JJY Instrumentation Lab GEM Creatine Control	2011-11-08
PMN K061974 | CGA BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit PVP Kit	2011-11-08
PMN K061974 | CGA BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit Check	2011-11-08
PMN K061974 | CEM BIONOSTICS, INC.	JJY Instrumentation Lab GEM Creatine Control	2011-11-08
PMN K061974 | CEM BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit PVP Kit	2011-11-08
PMN K061974 | CEM BIONOSTICS, INC.	GLK Instrumentation Lab GEM Crit Check	2011-11-08
PMN K052762 | NBW BIONOSTICS, INC.	JJX WaveSense Glucose Control Solution	2011-11-08
PMN K052762 | JJX BIONOSTICS, INC.	JJX WaveSense Glucose Control Solution	2011-11-08
PMN K052762 | CGA BIONOSTICS, INC.	JJX WaveSense Glucose Control Solution	2011-11-08
PMN K043474 | NBW BIONOSTICS, INC.	JJX Roche AccuCheck AVIVA Glucose Control	2011-11-08
PMN K043474 | LFR BIONOSTICS, INC.	JJX Roche AccuCheck AVIVA Glucose Control	2011-11-08
PMN K043474 | JJX BIONOSTICS, INC.	JJX Roche AccuCheck AVIVA Glucose Control	2011-11-08
PMN K043245 | NBW BIONOSTICS, INC.	Glucose Control Solution for EPS Biotech BGMS	2011-11-08
PMN K043245 | JJX BIONOSTICS, INC.	Glucose Control Solution for EPS Biotech BGMS	2011-11-08
PMN K043245 | CGA BIONOSTICS, INC.	Glucose Control Solution for EPS Biotech BGMS	2011-11-08
PMN K042678 | NBW BIONOSTICS, INC.	JJX Bionime Rightest Glucose Control Solution	2011-11-08
PMN K042678 | NBW BIONOSTICS, INC.	JJX Bionime G700 Glucose Control Solution	2011-11-08
PMN K042678 | JJX BIONOSTICS, INC.	JJX Bionime Rightest Glucose Control Solution	2011-11-08
PMN K042678 | JJX BIONOSTICS, INC.	JJX Bionime G700 Glucose Control Solution	2011-11-08
PMN K042678 | CGA BIONOSTICS, INC.	JJX Bionime Rightest Glucose Control Solution	2011-11-08
PMN K042678 | CGA BIONOSTICS, INC.	JJX Bionime G700 Glucose Control Solution	2011-11-08
PMN K031472 | NBW BIONOSTICS, INC.	LifeScan OneTouch Basic Control Solution	2011-11-08
PMN K031472 | CGA BIONOSTICS, INC.	LifeScan OneTouch Basic Control Solution	2011-11-08
PMN K030703 | NBW BIONOSTICS, INC.	NIPRO TRUEtrack Control Solution	2011-11-08
PMN K030703 | NBW BIONOSTICS, INC.	NIPRO TRUEcontrol Solution	2011-11-08
PMN K022158 | JJY BIONOSTICS, INC.	JJY Instrumentation Lab Gem Crit PVP Kit	2011-11-08
PMN K022158 | JJY BIONOSTICS, INC.	JJY Instrumentation Lab GEM PVP Kit	2011-11-08
PMN K022158 | JJY BIONOSTICS, INC.	JJY Instrumentation Lab GEM Crit Check Control	2011-11-08
PMN K022158 | JJY BIONOSTICS, INC.	JJY Instrumentation Lab GEM CVP Kit	2011-11-08
PMN K022158 | GFS BIONOSTICS, INC.	JJY Instrumentation Lab Gem Crit PVP Kit	2011-11-08
PMN K022158 | GFS BIONOSTICS, INC.	JJY Instrumentation Lab GEM PVP Kit	2011-11-08
PMN K022158 | GFS BIONOSTICS, INC.	JJY Instrumentation Lab GEM Crit Check Control	2011-11-08
PMN K022158 | GFS BIONOSTICS, INC.	JJY Instrumentation Lab GEM CVP Kit	2011-11-08
PMN K022158 | CGA BIONOSTICS, INC.	JJY Instrumentation Lab Gem Crit PVP Kit	2011-11-08
PMN K022158 | CGA BIONOSTICS, INC.	JJY Instrumentation Lab GEM PVP Kit	2011-11-08
PMN K022158 | CGA BIONOSTICS, INC.	JJY Instrumentation Lab GEM Crit Check Control	2011-11-08
PMN K022158 | CGA BIONOSTICS, INC.	JJY Instrumentation Lab GEM CVP Kit	2011-11-08
PMN K020232 | CGA BIONOSTICS, INC.	Assure Dose Glucose Control	2011-11-08
PMN K961807 | GLK BIONOSTICS, INC.	Siemens RapidQC Hematocrit Control	2011-10-25
PMN K961807 | GLK BIONOSTICS, INC.	Siemens RapidQC Hematocrit CVM Kit	2011-10-25
PMN K946224 | JJS BIONOSTICS, INC.	Siemens RapidQC CVM	2011-10-25
PMN K946224 | JJS BIONOSTICS, INC.	Siemens RapidQC COMPLETE Control	2011-10-25
PMN K870036 | JJS BIONOSTICS, INC.	Siemens RapidQC Plus Control	2011-10-25
PMN K841783 | JJS BIONOSTICS, INC.	RNA Medical QC123 pH/Blood Gas Control	2011-10-25
PMN K832028 | JJS BIONOSTICS, INC.	Siemens RapidQC CO-Ox Slope	2011-10-25
PMN K974822 | JJY BIONOSTICS, INC.	OPTI Medical OPTI-Check Control	2011-10-24
PMN K112356 | JJX BIONOSTICS, INC.	Glucose Meter-Check Solution for AgaMatrix WaveSense	2011-10-24
PMN K041107 | NBW BIONOSTICS, INC.	Vocal Point Glucose Control Solution	2011-10-24
PMN K041107 | NBW BIONOSTICS, INC.	Medpoint Glucose Control Solution	2011-10-24
PMN K041107 | NBW BIONOSTICS, INC.	MedNet Glucose Control Solution	2011-10-24
PMN K041107 | NBW BIONOSTICS, INC.	FORA Glucose Control Solution	2011-10-24
PMN K041107 | NBW BIONOSTICS, INC.	Easy Check Glucose Control Solution	2011-10-24
PMN K041107 | NBW BIONOSTICS, INC.	Clever Choice Glucose Control Solution	2011-10-24
PMN K041107 | NBW BIONOSTICS, INC.	Clever Check Glucose Control Solution	2011-10-24
PMN K041107 | NBW BIONOSTICS, INC.	Advocate Glucose Control Solution	2011-10-24
PMN K041107 | JJX BIONOSTICS, INC.	Vocal Point Glucose Control Solution	2011-10-24
PMN K041107 | JJX BIONOSTICS, INC.	Medpoint Glucose Control Solution	2011-10-24
PMN K041107 | JJX BIONOSTICS, INC.	MedNet Glucose Control Solution	2011-10-24
PMN K041107 | JJX BIONOSTICS, INC.	FORA Glucose Control Solution	2011-10-24
PMN K041107 | JJX BIONOSTICS, INC.	Easy Check Glucose Control Solution	2011-10-24
PMN K041107 | JJX BIONOSTICS, INC.	Clever Choice Glucose Control Solution	2011-10-24
PMN K041107 | JJX BIONOSTICS, INC.	Clever Check Glucose Control Solution	2011-10-24
PMN K041107 | JJX BIONOSTICS, INC.	Advocate Glucose Control Solution	2011-10-24
PMN K041107 | CGA BIONOSTICS, INC.	Vocal Point Glucose Control Solution	2011-10-24
PMN K041107 | CGA BIONOSTICS, INC.	Medpoint Glucose Control Solution	2011-10-24
PMN K041107 | CGA BIONOSTICS, INC.	MedNet Glucose Control Solution	2011-10-24
PMN K041107 | CGA BIONOSTICS, INC.	FORA Glucose Control Solution	2011-10-24
PMN K041107 | CGA BIONOSTICS, INC.	Easy Check Glucose Control Solution	2011-10-24
PMN K041107 | CGA BIONOSTICS, INC.	Clever Choice Glucose Control Solution	2011-10-24
PMN K041107 | CGA BIONOSTICS, INC.	Clever Check Glucose Control Solution	2011-10-24
PMN K041107 | CGA BIONOSTICS, INC.	Advocate Glucose Control Solution	2011-10-24
PMN K003239 | JJS BIONOSTICS, INC.	BIO-RAD LiquiCheck CO-Ox Control	2011-10-24
PMN K002866 | JJS BIONOSTICS, INC.	BIO-RAD LiquiCheck Blood Gas, Electrolyte Control	2011-10-24
PMN K002535 | JJS BIONOSTICS, INC.	BIO-RAD LiquiCheck Blood Gas, Electrolyte, Glucose Control	2011-10-24
PMN K002120 | JJS BIONOSTICS, INC.	BIO-RAD LiquiCheck Blood Gas Control	2011-10-24
PMN K001632 | JJY BIONOSTICS, INC.	OPTI Medical OPTI-Check PLUS Control	2011-10-24
PMN K112356 BIONOSTICS, INC.	GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE	2011-09-19
PMN K093724 | JJX BIONOSTICS, INC.	TaiDoc Clever-Check Glucose Control Solution	2011-06-27
PMN K093724 | JJX BIONOSTICS, INC.	FORA Glucose Control Solution	2011-06-27
PMN K103553 | JJX BIONOSTICS, INC.	LifeScan Verio Glucose Control Solution	2011-03-29
PMN K103553 | JJX BIONOSTICS, INC.	LifeScan OneTouch Vita Glucose Control Solution	2011-03-29
PMN K103553 | JJX BIONOSTICS, INC.	LifeScan OneTouch Ultra Glucose Control Solution	2011-03-29
PMN K103553 | JJX BIONOSTICS, INC.	LifeScan OneTouch Select Glucose Control Solution	2011-03-29
PMN K103553 | JJX BIONOSTICS, INC.	LifeScan OneTouch Horizon Glucose Control Solution	2011-03-29
PMN K103553 | JJX BIONOSTICS, INC.	LifeScan GlucoTouch Control Solution	2011-03-29
PMN K103553 | JJX BIONOSTICS, INC.	Glucose Meter-Check Solution for LIfeScan	2011-03-29
PMN K101831 | OSL BIONOSTICS, INC.	Enterix iFOB Control	2011-03-29
PMN K103553 BIONOSTICS, INC.	LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION	2011-02-10
PMN K101831 BIONOSTICS, INC.	ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800	2010-10-01
PMN K911755 | JJY BIONOSTICS, INC.	RNA Medical QC623 Blood Gas/Electrolyte Controls	2010-05-03
PMN K091914 BIONOSTICS, INC.	OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION	2009-11-06
PMN K972868 | JJY BIONOSTICS, INC.	Roche COMBITROL PLUS Control	2009-10-28
PMN K972868 | JJY BIONOSTICS, INC.	Roche AUTOTROL PLUS Control	2009-10-28
PMN K972868 | JJY BIONOSTICS, INC.	RNA Medical CC525 Blood Gas, Electrolyte, Metabolite, CO-Oximetry Control	2009-10-28
PMN K972868 | JJY BIONOSTICS, INC.	APOC i-STAT TriControls Calibration Verification Kit	2009-10-28
PMN K972868 | JJY BIONOSTICS, INC.	APOC i-STAT CHEM 8+ Control	2009-10-28
PMN K972868 | JJY BIONOSTICS, INC.	APOC i-STAT CHEM 8+ Calibration Verifier Kit	2009-10-28
PMN K972868 | JJY BIONOSTICS, INC.	APOC i-STAT 1 Controls	2009-10-28
PMN K972868 | JJY BIONOSTICS, INC.	APOC i-STAT 1 Calibration Verification Kit	2009-10-28
PMN K063398 | DIF BIONOSTICS, INC.	ESA LeadCare II Lead Control	2009-10-28
PMN K053327 | JJX BIONOSTICS, INC.	Waters OXYCOM tHb/SO2 Control	2009-10-28
PMN K050961 | JJX BIONOSTICS, INC.	Axis-Shield NycoCard HbA1c Control	2009-10-28
PMN K032453 | JJY BIONOSTICS, INC.	Roche COMBITROL PLUS B Control	2009-10-28
PMN K032453 | JJY BIONOSTICS, INC.	Roche CO-Ox/MSS Verifier Kit	2009-10-28
PMN K032453 | JJY BIONOSTICS, INC.	Roche AUTOTROL PLUS B Control	2009-10-28
PMN K021930 | JJY BIONOSTICS, INC.	MEDICA EasyQC BG/ISE Control	2009-10-28
PMN K021924 | GLK BIONOSTICS, INC.	MEDICA EasyQC Hematocrit Control	2009-10-28
PMN K021697 | JJX BIONOSTICS, INC.	Glucose Meter Check - Nova BGM	2009-10-28
PMN K013147 | JJX BIONOSTICS, INC.	Papillion Mini Glucose Control	2009-10-28
PMN K013147 | JJX BIONOSTICS, INC.	Optium Glucose Control	2009-10-28
PMN K013147 | JJX BIONOSTICS, INC.	Glucose Meter-Check Solution for Abbott	2009-10-28
PMN K013147 | JJX BIONOSTICS, INC.	Alpha-Trak Glucose Control	2009-10-28
PMN K013147 | JJX BIONOSTICS, INC.	ADC FreeStyle Glucose Control	2009-10-28
PMN K012431 | JJY BIONOSTICS, INC.	Roche TS/MSS Verifier Kit	2009-10-28
PMN K012431 | JJY BIONOSTICS, INC.	Roche COMBITROL TS PLUS Control	2009-10-28
PMN K012431 | JJY BIONOSTICS, INC.	Roche AUTOTROL TS PLUS Control	2009-10-28
PMN K012431 | JJY BIONOSTICS, INC.	HESKA COMBITROL TS PLUS Control	2009-10-28
PMN K082395 | JJX BIONOSTICS, INC.	Glucose Meter Check - Bayer BGM	2008-11-07
PMN K081478 | JJX BIONOSTICS, INC.	RNA Medical Glucose & B-Ketone CVC	2008-11-07
PMN K081403 | JJX BIONOSTICS, INC.	Glucose Meter Check - Roche BGM	2008-11-07
PMN K081478 BIONOSTICS, INC.	RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS	2008-10-06
PMN K082395 BIONOSTICS, INC.	GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002	2008-09-18
PMN K081403 BIONOSTICS, INC.	GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK	2008-07-25
PMN K980178 | JJY BIONOSTICS, INC.	RNA Medical QC253 CO-Oximeter Control	2007-12-18
PMN K980178 | JJY BIONOSTICS, INC.	RNA Medical CVC223 CO-Oximeter CVC	2007-12-18
PMN K955630 | JJR BIONOSTICS, INC.	RNA Medical QC900 Hematocrit Controls	2007-12-18
PMN K955630 | JJR BIONOSTICS, INC.	RNA Medical Hematocrit Controls for i-STAT	2007-12-18
PMN K955630 | JJR BIONOSTICS, INC.	RNA Medical Hematocrit CVC for i-STAT	2007-12-18
PMN K955630 | JJR BIONOSTICS, INC.	RNA Medical CVC9005 Hematocrit CVC	2007-12-18
PMN K955630 | GLK BIONOSTICS, INC.	RNA Medical QC900 Hematocrit Controls	2007-12-18
PMN K955630 | GLK BIONOSTICS, INC.	RNA Medical Hematocrit Controls for i-STAT	2007-12-18
PMN K955630 | GLK BIONOSTICS, INC.	RNA Medical Hematocrit CVC for i-STAT	2007-12-18
PMN K955630 | GLK BIONOSTICS, INC.	RNA Medical CVC9005 Hematocrit CVC	2007-12-18
PMN K950399 | JJY BIONOSTICS, INC.	RNA Medical QC463 EQUIL Plus Control	2007-12-18
PMN K943754 | JJY BIONOSTICS, INC.	Roche COMBITROL Control	2007-12-18
PMN K943754 | JJY BIONOSTICS, INC.	Roche AUTOTROL Control	2007-12-18
PMN K943754 | JJY BIONOSTICS, INC.	RNA Medical QC823 Range Control	2007-12-18
PMN K943754 | JJY BIONOSTICS, INC.	RNA Medical QC823 Control	2007-12-18
PMN K943754 | JJY BIONOSTICS, INC.	RNA Medical CVC123 CVC Kit	2007-12-18
PMN K880447 | JJY BIONOSTICS, INC.	RNA Medical CC527 Control	2007-12-18
PMN K874408 | JJS BIONOSTICS, INC.	RNA Medical Blood Gas Controls	2007-12-18
PMN K021624 | JJX BIONOSTICS, INC.	RNA Medical GL4 Glucose Controls	2007-12-18
PMN K833146 | JJS BIONOSTICS, INC.	Roche CONFITEST III Blood Gas Control	2007-12-12
PMN K063398 BIONOSTICS, INC.	ESA LEADCARE II LEAD CONTROL	2006-12-05
PMN K853776 | JPK BIONOSTICS, INC.	RNA Medical QCHGB Control	2006-07-03
GIO BIONOSTICS, INC.	RNA Medical CT220 Safe-Wrap Tubes	2006-07-03
GIO BIONOSTICS, INC.	RNA Medical CT095 Safe-Wrap Tubes	2006-07-03
PMN K053327 BIONOSTICS, INC.	OXICOM CONTROL	2006-01-26
PMN K050961 BIONOSTICS, INC.	RNA1C CONTROL FOR NYCOCARD HBA1C	2005-05-13
PMN K050100 BIONOSTICS, INC.	RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER	2005-02-25
PMN K032453 BIONOSTICS, INC.	ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL	2003-08-28
PMN K022769 BIONOSTICS, INC.	LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION	2002-11-13
PMN K021697 BIONOSTICS, INC.	GLUCOSE CONTROL SOLUTION FOR BD LATITUDE	2002-07-12
PMN K021624 BIONOSTICS, INC.	RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4	2002-07-12
PMN K021930 BIONOSTICS, INC.	MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL	2002-06-25
PMN K021924 BIONOSTICS, INC.	MEDICA EASYQC HEMATOCRIT CONTROL	2002-06-24
PMN K013147 BIONOSTICS, INC.	GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE	2001-10-24
PMN K012431 BIONOSTICS, INC.	COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3	2001-08-28
PMN K012430 BIONOSTICS, INC.	MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3	2001-08-27
PMN K050100 | JJX BIONOSTICS, INC.	RNA Medical RNA1c HbA1c Control for Siemens DCA / Vantage	2001-06-18
PMN K002540 BIONOSTICS, INC.	BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS	2000-09-18
PMN K000318 BIONOSTICS, INC.	BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM	2000-02-28
PMN K980178 BIONOSTICS, INC.	OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY	1998-02-12
PMN K972868 BIONOSTICS, INC.	TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL	1997-08-28
PMN K955630 BIONOSTICS, INC.	RNA MEDICAL HEMAT CONTROL	1996-03-01
PMN K950399 BIONOSTICS, INC.	RNA MEDICAL'S EQUIL PLUS WITH GLUCOSE CONTROL	1995-02-22
PMN K943754 BIONOSTICS, INC.	BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT	1994-09-14
PMN K880710 | JJR BIONOSTICS, INC.	Roche ISETROL Control	1993-01-04
PMN K880710 | JJR BIONOSTICS, INC.	RNA Medical CVC323 ISE CVC Kit	1993-01-04
PMN K880710 | JJR BIONOSTICS, INC.	OPTI Medical OPTI-Check Lytes Control	1993-01-04
PMN K880710 | JJR BIONOSTICS, INC.	IDEXX VetLyte Electrolyte Control	1993-01-04
PMN K922357 BIONOSTICS, INC.	RNA MEDICAL'S EQUIL 55	1992-06-30
PMN K922386 BIONOSTICS, INC.	RNA MEDICAL TONOMETER	1992-06-26
PMN K913133 BIONOSTICS, INC.	CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED)	1991-09-27
PMN K911755 BIONOSTICS, INC.	CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE	1991-05-22
PMN K904698 BIONOSTICS, INC.	SECONDARY CALIBRATORS	1990-11-28
PMN K904335 BIONOSTICS, INC.	SECONDARY CALIBRATORS	1990-10-12
PMN K880447 BIONOSTICS, INC.	MULTI-FUNCTION BLOOD GAS CONTROL	1988-05-27
PMN K880710 BIONOSTICS, INC.	PROTEIN BASE ISE CONTROL	1988-03-24
PMN K874408 BIONOSTICS, INC.	MULTI-FUNCTION BLOOD GAS CONTROL	1987-12-14
PMN K851911 BIONOSTICS, INC.	MULTI FUNCTION BLOOD GAS CONTROL	1985-05-20
PMN K841783 BIONOSTICS, INC.	BLOOD GAS CONTROL, LEVEL I(ACIDOSIS	1984-06-14
PMN K840843 BIONOSTICS, INC.	POTASSIUM CHLORIDE TABLETS	1984-04-17
PMN K840300 BIONOSTICS, INC.	FLUSH SOLUTION CONCENTRATE-BLOOD GAS	1984-03-23
PMN K840299 BIONOSTICS, INC.	PH ELECTRODE CALIBRATING BUFFERS-BLOOD	1984-03-23
PMN K833146 BIONOSTICS, INC.	AQUEOUS BLOOD GAS CONTROL	1983-11-28
PMN K831872 BIONOSTICS, INC.	CALIBRATOR 282	1983-07-18

Related Finance Registrations

NCAGE Code	1QNL4	BIONOSTICS INC
CAGE Code	1QNL4	BIONOSTICS INC
CAGE Code	5S368	BIONOSTICS INC. RNA MEDICAL DIVISION RNA MEDICAL
S.A.M. Registration	5S368 [101187037]	BIONOSTICS INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091914573	Anvers,Belgium -> New York, New York	SAID TO CONTAIN RUBBER MAT HS CODE 40169997 EX KN LNZ 1830-0874-008.011 CONTENTS AND DETAILS AS PER SHIPPERS DECLARATION	1 PKG
2020091225924	Anvers,Belgium -> New York, New York	SAID TO CONTAIN RUBBER MAT HS CODE 40169997 EX KN LNZ 1830-0874-008.011 CONTENTS AND DETAILS AS PER SHIPPERS DECLARATION	1 PKG
2020091132431	Anvers,Belgium -> New York, New York	SAID TO CONTAIN RUBBER MAT HS CODE 40169997 EX KN LNZ 1830-0874-008.011 CONTENTS AND DETAILS AS PER SHIPPERS DECLARATION	1 PKG
2020091028060	Anvers,Belgium -> New York, New York	SAID TO CONTAIN RUBBER MAT HS CODE 40169997 EX KN LNZ 1830-0874-008.011 CONTENTS AND DETAILS AS PER SHIPPERS DECLARATION	1 PKG
2020090225832	Genova,Italy -> New York/Newark Area, Newark, New Jersey	EMPTY GLASS AMPOULES INV.387 PO 18856 . CIF BOSTON MA . HS-CODE 70101000	8 PCS
2020082849878	Anvers,Belgium -> New York, New York	SAID TO CONTAIN RUBBER MAT HS CODE 40169997 EX KN LNZ 1830-0874-008.011 CONTENTS AND DETAILS AS PER SHIPPERS DECLARATION	1 PKG
2020082756373	Anvers,Belgium -> New York, New York	SAID TO CONTAIN RUBBER MAT HS CODE 40169997 EX KN LNZ 1830-0874-008.011 CONTENTS AND DETAILS AS PER SHIPPERS DECLARATION	1 PKG
2020082653328	Anvers,Belgium -> New York, New York	SAID TO CONTAIN RUBBER MAT HS CODE 40169997 EX KN LNZ 1830-0874-008.011 CONTENTS AND DETAILS AS PER SHIPPERS DECLARATION	1 PKG