INOVA DIAGNOSTICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20269942026994INOVA DIAGNOSTICS, INC.1Y2026-01-019900 Old Grove Rd SAN DIEGO CA US 92131

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
08430793040518Aptiva® Celiac Disease IgG Calibrators - The Celiac Disease IgG Calibrators include antibodies to tTG and DGP. 1. Aptiva Celiac IgG Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives. 2. Aptiva Celiac IgG Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives. 3. Aptiva Celiac IgG Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives.1-800-545-9495support@inovadx.com
08430793040525Aptiva® Celiac Disease IgG Controls - The Celiac Disease IgG Controls include antibodies to tTG and DGP. 1. Aptiva Celiac IgG Control 1: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers and preservatives. 2. Aptiva Celiac IgG Control 2: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers, and preservatives.1-800-545-9495support@inovadx.com
08430793040570Aptiva® Celiac Disease IgA Calibrators - The Celiac Disease IgA Calibrators include antibodies to tTG and DGP. 1. Aptiva Celiac IgA Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives. 2. Aptiva Celiac IgA Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives. 3. Aptiva Celiac IgA Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives.1-800-545-9495support@inovadx.com
08430793040587Aptiva® Celiac Disease IgA Controls - The Celiac Disease IgA Controls include antibodies to tTG and DGP 1. Aptiva Celiac IgA Control 1: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers and preservatives. 2. Aptiva Celiac IgA Control 2: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers, and preservatives.1-800-545-9495support@inovadx.com
08430793040839Aptiva® APS IgA Calibrators - 1.Aptiva APS IgA Calibrator 1 (2x0.3mL) 2. Aptiva APS IgA Calibrator 2 (2x0.3mL) 3. Aptiva APS IgA Calibrator 3 (2x0.3mL)1-800-678-0710TechSupport.na@werfen.com
08430793040907Aptiva® APS IgM Calibrators - 1.Aptiva APS IgM Calibrator 1 (2x0.3mL) 2. Aptiva APS IgM Calibrator 2 (2x0.3mL) 3. Aptiva APS IgM Calibrator 3 (2x0.3mL)1-800-678-0710TechSupport.na@werfen.com
08430793040914Aptiva® APS IgM Controls - 1. Aptiva APS IgM Contros 1 (2x0.5mL) 2.Aptiva APS IgM Control 2 (2x0.5mL)1-800-678-0710TechSupport.na@werfen.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
347201734035087K993727BINDAZYME ANTI-DSDNA EIA KITLRM1999-12-21
347201048614727K991657QUANTA LITE ANA ELISALLL1999-06-17
347201670348512K984336QUANTA LITE GBM ELISAMVJ1999-02-08
347201550050415K983084QUANTA LITE RF IGA ELISADHR1998-11-04
347201608502001K983083QUANTA LITE RF IGG ELISADHR1998-11-04
347201545027722K982790QUANTA LITE H. PYLORI IGG ELISALYR1998-11-04
347201345899573K982603QUANTA LITE CHROMATIN ELISALLL1998-10-07
347201537610714K982366QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISAMVM1998-08-27
347201451919244K981857QUANTA LITE TPO ELISALLL1998-07-29
347201882142720K981330QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KITMOB1998-06-19
347202042229501K981328QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KITMOB1998-06-19
347201876162747K981237QUANTA LITE RIBOSOME P ELISAMQA1998-06-05
347201055586509K981209MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITSMVM1998-10-22
347201837558811K981030BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KITMOB1998-07-20
347201254630630K981029BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KITMOB1998-07-20
347201920817720K980230QUANTA LITE B2 GPI SCREENMSV1998-03-24
347201262812880K973014QUANTA LITE B2GPI IGMMSV1997-10-20
347201678907943K973006QUANTA LITE B2 GPI IGAMSV1997-10-20
347201763409652K971614QUANTA LITE RF IGMDHR1997-06-20
347201390004229K970551QUANTA LITE B2GPI IGGMSV1997-06-24
347201770488290K965133ANCA COMBI DIAGNOSTIC TEST KITMOB1997-05-21
347201199006594K964986QUANTA LITE IGA GLIADIN ELISAMST1997-06-02
347201580257627K964985QUANTA LITE IGG GLIADIN ELISAMST1997-05-30
347201173689499K961913QUANTA LITE ENA 6 ELISALLL1996-07-10
347201283713761K961340NOVA LITE ANCAMOB1996-07-10
347201160813636K955431RIT LIVER, KIDNEY, STOMACH IFA KITDBL1996-04-23
347201349055463K954380QUANTA LITE SSDNALJM1996-02-29
347201269875255K953366QUANTA LITE IGA ACA (HRP)MID1995-09-01
347201761240518K953291QUANTA LITE ACA SCREEN (HRP)MID1995-08-29
347201305823427K946385QUANTA LITE ACA IGM (HRP)MID1995-07-18
347201833022351K946034QUANTA LITE(TM) IGG (HRP)MID1995-07-18
347201950911624K943076QUANTA LITE ENA 5 ELISA KITLLL1994-10-25
347201611367989K934053QUANTA LITE(TM) HISTONE ELISALLL1993-12-21
347201581414188K930486QUANTA LITE(TM) THYROID T ELISADDC1993-03-15
347201206874616K926562QUANTA LITE(TM) JO-1 ELISA KITLLL1993-03-04
347201692378276K924898QUANTA LITE(TM) SCL-70 ELISALLL1992-12-15
347201601566457K922833QUANTA LITE RNP ELISALLL1992-09-18
347201500270281K922832QUANTA LITE SS-B ELISALLL1992-09-18
347201344353349K922831QUANTA LITE SM ELISALLL1992-09-18
347201252205292K922830QUANTA LITE SS-A ELISALLL1992-09-18
347201109815954K922829QUANTA LITE ENA ELISALLL1992-09-18
347201180357190K904224NOVA LITE TM THYROIDJZO1990-10-15
347201224991177K903898QUANTA LITE TM DSDNALLL1990-09-05
347201806476943K901596NOVA LITE(TM) ANA KSLDHN1990-05-02
347201540927946K881340NOVA LITE(TM) AUTOANTIBODY CONTROLSLLL1988-06-08
347201583377553K881339NOVA LITE(TM) ANA PLUSLLL1988-04-21
347201888851944K880742NOVA LITE(TM) DSDNADHN1988-03-25
347201735564790K880736NOVA LITE(TM) ANALLL1988-03-25
347201506068232K243979Aptiva APS IgA ReagentMSV2026-02-06
347201572064932K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentMID2024-12-17
347201523618676K213403Aptiva CTD Essential ReagentLLL2023-09-29
347201802154783K200230Aptiva Celiac Disease IgG ReagentMVM2021-08-26
347201832219793K193604Aptiva Celiac Disease IgA ReagentMVM2021-06-16
347201888713813K192916NOVA Lite DAPI dsDNA Crithidia luciliae KitKTL2020-12-11
347201438539730K191592CalprestNG, EasyCalNXO2019-07-10
347201399243879K190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsDHR2019-04-17
347201821315703K180975QUANTA Flash HMGCR ReagentsLLL2018-06-25
347201799548336K180971QUANTA Flash Calprotectin and Fecal Extraction DeviceNXO2018-10-16
347201627701102K170993QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction BufferNXO2017-12-22
347201015070336K170314ACL AcuStarJPA2017-03-03
347201555476912K163538QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 ControlsNBS2017-09-06
347201945069750K163525QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) ControlsDBM2017-09-05
347201040191880K161258NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitMOB2017-02-03
347201865362297K160447Calprest NGNXO2016-11-10
347201960751830K153150AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000PIV2015-11-24
347201007284345K152875QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 ControlsMSV2015-12-21
347201863685900K152635QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 ControlsLLL2016-06-01
347202069976469K152013QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA ControlsLSW2016-04-11
347201277430781K151429QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsLLL2016-02-12
347201938840725K150155NOVA Lite DAPI ANA KitDHN2015-04-08
347201901952665K143754QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3NHX2015-09-21
347201676592829K141655QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLSOBE2015-03-05
347202065479762K141328QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLSLLL2015-02-12
347201931703442K141210QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLSLLL2015-01-29
347201315677513K130945CALPRESTNXO2014-01-16
347201639586014K123880QUANTA FLASH CENTROMERELJM2014-02-07
347201788924583K123593QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,LKP2013-04-17
347201304930104K122923QUANTA FLASH ENA7LLL2013-05-07
347201230275062K120817QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGAMID2013-02-26
347201981195162K113863QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORSMST2012-09-20
347201322530214K112545QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBMMOB2012-07-31
347201286369195K111414QUANTA FLASH (TM) DGP SCREENMST2011-10-20
347201529569518K101644QUANTA FLASH H-TTG IGGMVM2011-03-23
347201007771339K094060QUANTA FLASH H-TTG IGAMVM2010-10-13
347201065424695K092181HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLSMID2010-03-11
347201050333535K091556HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLSMSV2010-05-21
347201427979194K090755QUANTA LITE APS/PT IGG AND IGM ELISAOPN2010-02-01
347201692565740K081248QUANTA LITE OMP PLUS ELISAOKM2008-10-27
347201329177378K073145QUANTA LITE H-TTG SCREENMVM2008-02-12
347201153548732K072967QUANTA LITE F-ACTIN IGA ELISAMVM2008-01-28
347201617764541K072944QUANTA LITE CCP3.1 IGG/IGA ELISANHX2008-03-05
347201333071313K070083QUANTA LITE H-TTG/DGP SCREENMST2007-03-12
347201748463866K070066QUANTA LITE RNA POL III ELISANYO2007-04-11
347201617562598K063565QUANTA LITE SS-A 52 ELISAOBE2007-04-04
347201586607396K062708QUANTA LITE CELIAC DGP SCREENMST2006-12-13
347201925476624K062183FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KITLRM2006-11-21
347201168173624K061842QUANTA LITE PBC SCREEN IGG/IGA ELISANRI2006-10-18
347201301759776K061841QUANTA LITE INTRINSIC FACTOR ELISALIG2006-12-22
347201836672412K052264QUANTA LITE CCP3 IGG ELISANHX2005-11-23
347201292730001K052262QUANTA LITE M2 EP (MIT3) ELISADBM2005-10-27
347201280041280K052143QUANTA LITE GLIADIN IGA IIMST2005-10-04
347201939225283K052142QUANTA LITE GLIADIN IGG IIMST2005-10-04
347201946394871K050662QUANTA LITE SP100 ELISANUM2005-06-13
347201728527116K040885QUANTA LITE GP210 ELISANRI2004-06-25
347201875479606K040466BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITSMVM2004-07-16
347201907881586K032240BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KITMID2003-09-29
347201245624373K031563BINDAZYME CLQ CIC EIA KITDAK2003-09-10
347201735260499K024334QUANTA LITE H.PYLORI IGA ELISALYR2003-03-27
347201785077827K021648QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISANJF2002-09-20
347201954600929K021482QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISANIY2002-07-30
347201962780660K011570QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISAMVM2001-07-09
347201982509282K011566QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISAMVM2001-07-09
347201226865973K010558QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISAMLE2001-04-03
347201502863433K003959QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISALJM2001-01-22
347201264384754K000733QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISANBT2001-05-21
347201051291847K000535QUANTA LITE LKM-1 ELISANBS2000-06-07
347201468368408DEN140039NOVA View Automated Fluorescense MicroscopePIV2015-04-09
347201349281767DEN000007QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISANBT2000-08-16
347201100963200
347201162103156

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLL242023-09-29
MVM112021-08-26
MID82024-12-17
MOB82017-02-03
MST82012-09-20
MSV72026-02-06
NXO52019-07-10
DHR42019-04-17
NHX32015-09-21
DHN32015-04-08
LJM32014-02-07
NBS22017-09-06
DBM22017-09-05
PIV22015-11-24
OBE22015-03-05
LRM22006-11-21
NRI22006-10-18
LYR22003-03-27
NBT22001-05-21
KTL12020-12-11
JPA12017-03-03
LSW12016-04-11
LKP12013-04-17
OPN12010-02-01
OKM12008-10-27
NYO12007-04-11
LIG12006-12-22
NUM12005-06-13
DAK12003-09-10
NJF12002-09-20
NIY12002-07-30
MLE12001-04-03
MVJ11999-02-08
MQA11998-06-05
DBL11996-04-23
DDC11993-03-15
JZO11990-10-15

PMN#

133 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next