FDA.reportPublic FDA data

Nova-Biomedical-Corp

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12190291219029NOVA BIOMEDICAL CORPORATION1N2026-01-01200 Prospect St WALTHAM MA US 02454
30041934893004193489NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS1N2026-01-0139 Manning Rd Billerica MA US 01821
30119798583011979858Nova Biomedical Corporation1N2026-01-01165 Lexington Rd Billerica MA US 01821
30231626593023162659Nova Biomedical Corporation1N2026-01-014 Enterprise Road Billerica MA US 01821

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00385480533980STATSTRIP - Statstrip Glucose Meter with Battery and Quick Reference Guide+1(800)545-6682info@novabio.com
00385480533997STATSTRIP - Statstrip Glucose Meter with Battery and Quick Reference Guide Remanufactured+1(800)545-6682info@novabio.com
00385480547901STATSTRIP - Statstrip Glucose Meter with Battery and Quick Reference Guide+1(800)545-6682info@novabio.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
300701975487245K993104STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATORGLY1999-12-02
300701883978766K982277MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)CHL1998-07-22
300701746470380K980991NOVA STAT PROFILE PHOX BLOOD GAS ANALYZERCHL1998-04-15
300701458989581K963005NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)JFL1996-08-23
300701040999907K962997NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3JJY1996-08-15
300701044112889K962982NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREATJJY1996-08-23
300701041625614K955264NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2JJY1996-02-02
300701025739909K955260NOVA CHEMISTRY PERFORMANCE CHECK SOLUTIONJJY1996-02-02
300701313365480K955252NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4JJY1996-02-02
300701094959471K955013NOVA CO-OXIMETER ANALYZERGLY1996-04-25
300701611850363K945584NOVA 16 ANALYZERJJC1995-02-08
300701825246707K924864NOVA 13 ANALYZER, MODIFICATIONCGZ1992-11-06
300701637791427K924743NOVA 12 ANALYZER, MODIFICATIONCGA1992-11-06
300701111238330K924547NOVA 8 CRT ANALYZERJGS1993-01-28
300701104609068K923806ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATERJGS1992-09-29
3056161104609068K923806ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATERJGS1992-09-29
300701691896377K922215NOVA 14 NA/K/CL/GLU/BUN ANALYZERJGS1992-07-17
3056161691896377K922215NOVA 14 NA/K/CL/GLU/BUN ANALYZERJGS1992-07-17
300701436286001K915178NOVA 11 NA/K/LI ANALYZERCEM1992-01-27
300701952611174K915177NOVA 5 NA/K/C1 ALALYZERCEM1992-01-27
300701362919385K915176NOVA 4 NA/K/C1/TCO2/LI ANALYZERJGS1992-01-15
300701797852842K912561NOVA 13 ANALYZERCGZ1991-09-11
300701619989027K912560NOVA 12 ANALYZERJGS1991-07-17
300701703243504K912559NOVA 1 SODIUM/POTASSIUM/HEMATOCRIT ANALYZERJGS1991-07-01
300702066218161K232075StatStrip Glucose Hospital Meter SystemPZI2024-02-23
300732066218161K232075StatStrip Glucose Hospital Meter SystemPZI2024-02-23
1875692066218161K232075StatStrip Glucose Hospital Meter SystemPZI2024-02-23
300701879055296K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX2024-11-19
300701865403146K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerLCP2024-11-22
3056161865403146K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerLCP2024-11-22
300701223961062K203549Nova Primary Glucose Analyzer SystemCGA2022-10-18
3056161223961062K203549Nova Primary Glucose Analyzer SystemCGA2022-10-18
300701543467385K191626Stat Profile Prime ES Comp Plus Analyzer SystemJFP2019-08-16
3056161543467385K191626Stat Profile Prime ES Comp Plus Analyzer SystemJFP2019-08-16
300701771284210K191365Stat Profile Prime ES Comp Plus Analyzer SystemJGS2019-07-19
3056161771284210K191365Stat Profile Prime ES Comp Plus Analyzer SystemJGS2019-07-19
300701999418786K180428Stat Profile Prime Plus Analyzer SystemJGS2018-08-15
3056161999418786K180428Stat Profile Prime Plus Analyzer SystemJGS2018-08-15
300702029668379K180340Stat Profile Prime Plus Analyzer SystemCGA2018-09-26
3056162029668379K180340Stat Profile Prime Plus Analyzer SystemCGA2018-09-26
300701581561107K180186Stat Profile Prime Plus Analyzer SystemGGZ2018-08-23
3056161581561107K180186Stat Profile Prime Plus Analyzer SystemGGZ2018-08-23
300702044737267K173797Stat Profile Prime Plus Analyzer SystemCHL2018-07-17
3056162044737267K173797Stat Profile Prime Plus Analyzer SystemCHL2018-07-17
300701630846438K160990Nova Max Uric Acid Monitoring SystemPTC2017-04-11
300731630846438K160990Nova Max Uric Acid Monitoring SystemPTC2017-04-11
1875691630846438K160990Nova Max Uric Acid Monitoring SystemPTC2017-04-11
300701887404199K160156StatStrip Xpress Blood Glucose Monitoring SystemNBW2016-06-23
300731887404199K160156StatStrip Xpress Blood Glucose Monitoring SystemNBW2016-06-23
1875691887404199K160156StatStrip Xpress Blood Glucose Monitoring SystemNBW2016-06-23
300701500109321K152986StatStrip Xpress 2 Glucose Hospital Meter SystemPZI2016-01-27
300731500109321K152986StatStrip Xpress 2 Glucose Hospital Meter SystemPZI2016-01-27
1875691500109321K152986StatStrip Xpress 2 Glucose Hospital Meter SystemPZI2016-01-27
300701904831724K151982Stat Profile Prime ABG Analyzer SystemCHL2015-09-10
3056161904831724K151982Stat Profile Prime ABG Analyzer SystemCHL2015-09-10
300701928616518K150461StatStrip Xpress Glucose Hospital Meter SystemPZI2015-05-20
300731928616518K150461StatStrip Xpress Glucose Hospital Meter SystemPZI2015-05-20
1875691928616518K150461StatStrip Xpress Glucose Hospital Meter SystemPZI2015-05-20
300701068884172K150281StatStrip Glucose Hospital MeterPZI2015-05-06
300731068884172K150281StatStrip Glucose Hospital MeterPZI2015-05-06
1875691068884172K150281StatStrip Glucose Hospital MeterPZI2015-05-06
300701614154284K142220Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)CHL2014-10-17
3056161614154284K142220Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)CHL2014-10-17
300701554300555K141907STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET ACHL2015-05-29
3056161554300555K141907STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET ACHL2015-05-29
300701091831745K132121STATSTRIP GLUCOSE HOSPITAL METER SYSTEMPZI2014-09-24
300731091831745K132121STATSTRIP GLUCOSE HOSPITAL METER SYSTEMPZI2014-09-24
1875691091831745K132121STATSTRIP GLUCOSE HOSPITAL METER SYSTEMPZI2014-09-24
300701034979418K131703NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEMCHL2014-03-25
3056161034979418K131703NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEMCHL2014-03-25
300701139998119K131013FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEMNBW2013-10-17
300731139998119K131013FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEMNBW2013-10-17
1875691139998119K131013FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEMNBW2013-10-17
300701030665755K122688NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITORLFR2013-04-04
300731030665755K122688NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITORLFR2013-04-04
1875691030665755K122688NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITORLFR2013-04-04
300701596064511K122435NOVA ONE BLOOD GLUCOSE MONITORLFR2012-12-20
300731596064511K122435NOVA ONE BLOOD GLUCOSE MONITORLFR2012-12-20
1875691596064511K122435NOVA ONE BLOOD GLUCOSE MONITORLFR2012-12-20
300701028161658K112955NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEMKHP2012-01-05
300731028161658K112955NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEMKHP2012-01-05
1875691028161658K112955NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEMKHP2012-01-05
300731341697839K112638NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPSNBW2012-03-09
1875691341697839K112638NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPSNBW2012-03-09
300701782188511K110648NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEMCHL2011-08-29
3056161782188511K110648NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEMCHL2011-08-29
300701305013398K101633NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGHJJY2010-08-27
300701026743733K100602NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPSKHP2011-08-17
300731026743733K100602NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPSKHP2011-08-17
1875691026743733K100602NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPSKHP2011-08-17
300701332623063K091547NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOSNBW2010-01-15
300731332623063K091547NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOSNBW2010-01-15
1875691332623063K091547NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOSNBW2010-01-15
300701925453295K070960NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEMCGA2007-07-11
300731925453295K070960NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEMCGA2007-07-11
1875691925453295K070960NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEMCGA2007-07-11
300701791783450K070255NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002NBW2007-06-13
300731791783450K070255NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002NBW2007-06-13
1875691791783450K070255NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002NBW2007-06-13
300701333645815K070068NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPSCGL2007-05-07
300731333645815K070068NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPSCGL2007-05-07
1875691333645815K070068NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPSCGL2007-05-07
300702025041211K063821NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEMCGA2007-01-24
300732025041211K063821NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEMCGA2007-01-24
1875692025041211K063821NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEMCGA2007-01-24
300701356937103K061830STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+CIG2006-11-01
300701024279963K060345NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONSCGA2006-04-28
300731024279963K060345NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONSCGA2006-04-28
1875691024279963K060345NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONSCGA2006-04-28
300701433218216K041016NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONSJJX2004-05-07
300701804466547K040603PARADIGM LINK BLOOD GLUCOSE METERNBW2004-05-19
300731804466547K040603PARADIGM LINK BLOOD GLUCOSE METERNBW2004-05-19
1875691804466547K040603PARADIGM LINK BLOOD GLUCOSE METERNBW2004-05-19
300701115810915K033433NOVA GLUCOSE CONTROL SOLUTIONSJJX2004-01-02
300701986768658K023567STAT PROFILE PHOX PLUS L ANALYZERCHL2002-12-20
300701413773063K022746STAT PROFILE CRITICAL CARE XPRESS ANALYZERCHL2002-11-22
300701629452404K021713STAT PROFILE PHOX PLUS C ANALYZERCHL2002-07-25
3056161629452404K021713STAT PROFILE PHOX PLUS C ANALYZERCHL2002-07-25
300701221582306K020297STAT PROFILE CRITICAL CARE XPRESS ANALYZERCHL2002-06-10
300701099365813K014295STAT PROFILE PHOX ANALYZERCHL2002-02-28

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CHL262018-07-17
NBW172016-06-23
PZI152024-02-23
CGA142022-10-18
JGS132019-07-19
LFR62013-04-04
KHP62012-01-05
JJY62010-08-27
PTC32017-04-11
CGL32007-05-07
LCP22024-11-22
JFP22019-08-16
GGZ22018-08-23
JJX22004-05-07
GLY21999-12-02
CGZ21992-11-06
CEM21992-01-27
CGX12024-11-19
CIG12006-11-01
JFL11996-08-23
JJC11995-02-08

PMN#

126 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next