Joel Mathew

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
80219143002806332Joel Mathew1N2026-01-0112076 Santa Fe Trail Lenexa KS US 66215
30037502843003750284Joel Mathew1N2026-01-0112076 Santa Fe Trail Lenexa KS US 66215

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1364602016236018K991810MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TESTNGZ2001-10-09
76422022607418K983336PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1LKT1999-03-18
1364601485498892K983244SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)JTW1998-11-30
76421906671836K980507PROSPECT SHIGA TOXIN MICROPLATE ASSAYGMZ1998-04-23
1364601415807068K972576GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90LQL1998-01-22
76421470384874K971663WELLCOLEX E.COLI O157:H7GMZ1997-12-30
1364601993404449K965190SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATEJWY1997-03-19
1364601242746599K962867SENSITITRE 18 HOUR SUSCEPTIBILITY PLATESJWY1996-09-30
76421057423743K962028WELLCOLEX E-COLI OI57 ZC60GNA1996-11-01
1364601955202289K960366SENSITITRE 18 HOUR SUSCEPTIBILITY PLATESLTT1996-04-09
1364601860009391K960235SENSITITRE 18 HOUR SUSCEPTIBILITY PLATESJWY1996-03-27
1364601004977054K960220SENSITITRE 18 HOUR SUSCEPTIBILITY PLATESJWY1996-03-11
1364602073056055K951241HAEMOPHILUS/PNEUMOCOCCUS MIC PLATEJWY1995-10-07
76421216420389K945538STAPHAUREX PLUS(TM)JWX1995-06-01
76421896263531K943317PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)LKT1994-12-19
1364601506271003K936305SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATESJWY1995-07-13
1364601153159972K923045SENSITITRE SUSCEPTIBILITY PLATESJWY1993-03-09
76421140740102K915203D-DIMER WELLCOTEST (HA10)DAP1992-01-31
1364601693833833K912778HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATEJWY1992-02-18
1364602050170264K911419SENSITITRE ARIS MODULELRG1992-07-01
76421150341581K910797STREPTEX ACID EXTRACTION KITGTZ1991-03-29
76421298744846K904167PATHODX HERPES TYPINGGQL1990-12-13
76421149005618K902038PATHO DX STREP DGTZ1990-05-21
76421524924952K902037PATHODX PYR KITJTO1990-06-01
76421366088624K900870PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TESTLJP1990-04-16
76421085514635K895839PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1LJP1990-02-01
76421153961041K895461WELLCOLEX COLOUR SHIGELLA TEST ZC51GNB1990-01-11
76421667268971K890146WELLCOLEX COLOUR SALMONELLA TEST ZL 50GRM1989-02-16
1364601964060231K890057SENSITITRE AUTO ID PLATE AP80LQM1989-06-09
76421342211402K884026ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KITGNA1989-02-03
76421301320098K881247MONO-PHILEKTN1988-04-07
1364601443166391K880641SENSITITRE STABILITY PLATESJWY1988-05-13
76421351371857K871831PATHO DX LATEX AGGLUTINATION STREP GROUPING KITGTZ1987-06-17
76421640996846K864998IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KITJSM1987-04-20
76421613843168K862607IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KITLIO1986-08-04
1364601410735413K860753SENSITITRE SUSCEPTIBILITY PLATESJWY1986-05-06
76421995565282K854852WELLCOGEN BACTERIAL ANTIGEN KITGTJ1986-02-04
76421587330745K854851WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24GTJ1986-02-04
76421622441381K851949STAPHAUREX ZL30GTN1985-05-22
76421437322554K844762MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51GTJ1985-06-04
76421387605815K842828STREPTEX ZL01JTO1984-08-15
76421979209146K842383PATHO DX LATEX AGGLUTINATION STREP AGTZ1984-07-02
76421136045581K841376WELLCOGEN S. PNEUMONIAEGWC1984-05-02
76422061050926K833077WELLCOGEN H. INFLUENZAL ZL21GRD1984-01-10
76421657290957K833063WELLCOGEN N. MENINGITIDIS A,C,Y W135GTJ1984-01-10
76421321677139K822662REAGIN ANTIGEN SUSPENSIONGMQ1982-09-21
76421231604886K820069WELLCOGEN GROUP BGTZ1982-02-18
1364601295192019K802957MUELLER HINTON BROTHJTZ1980-12-22
76421672701374K780874THYMUNE-TDDC1978-06-14
76421767894593K780873THYMUNE-MDDC1978-06-14
76421940576705K771562AGGLUTINATING SERUM W135GTJ1977-08-25
1364601608126653K250990The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mLJWY2025-06-30
1364601945908889K243201The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mLJWY2025-02-10
1364601142015893K243169The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mLJWY2024-12-19
1364601302546987K242905The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mLJWY2025-02-10
1364601084307362K242659The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mLJWY2025-05-22
1364601858960609K242658The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mLJWY2025-04-15
1364601030154947K241967The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml.JWY2024-10-01
1364601681057703K240445The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml.JWY2024-05-16
1364601696328460K232310Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/mlJWY2023-10-31
1364601412318778K231994Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mLJWY2023-08-25
1364601664113230K231433The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mLNGZ2023-08-31
1364601219142086K202612Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL)JWY2021-07-23
1364601233868969K193538Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/mlJWY2020-03-12
1364601735040343K193024Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mLJWY2020-01-08
1364601991578472K192250Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mLJWY2019-10-16
1364601454642344K191918Thermo Scientific Sensititre ARIS HiQ SystemLRG2019-11-06
1364601792658900K191914Thermo Scientific Sensititre ARIS HiQ SystemLRG2019-11-06
1364602031854099K183324Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mLJWY2019-02-15
1364601430094805K183033Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/mlJWY2019-01-04
1364601234759171K182797Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mLJWY2018-11-30
1364601836076617K173209Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mLJWY2017-12-01
1364601094597448K172274The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mLJWY2017-08-30
1364602049827238K152774The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mLJWY2015-12-21
1364601008427335K150556Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL)JWY2015-08-28
1364601554483987K150236Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL)JWY2015-07-27
1364601489850097K143526The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml)JWY2015-03-05
1364601244302451K143381Sensititre Susceptibility PlatesJWY2015-02-19
1364601357508955K143288Sensititre Susceptibility platesJWY2015-04-01
1364601336689931K142338Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml)JWY2015-03-02
1364601293608859K142151SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATESJWY2014-12-23
1364601906394752K141651SENSITITRE SUSCEPTIBILITY PLATESJWY2014-10-21
1364601277302727K141000SENSITITRE SUSCEPTIBILITY PLATESJWY2014-07-16
1364601168286344K140985SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATESJWY2014-06-10
1364601145441536K133038SENSITITRE YEASTONE SUSCEPTIBILITY PLATESNGZ2014-01-31
1364602026961947K112276VIZIONJWY2011-11-16
1364601259436044K111429SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...JWY2011-08-18
1364601876434595K110583SENSITITRE OPTIREADLRG2011-09-22
1364601773403265K110331SENSITITRE AIM (TM)LIE2011-04-27
1364601917601398K103456THE SENSITITRE AIMLIE2011-06-22
1364601399283436K093865SENSITITRE 18-24HR SUSCEPTIBILITY PLATESJWY2010-02-17
1364601627035482K092445SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATESJWY2009-12-16
1364601390838725K090968SENSITITRE YEASTONE SUSCEPTIBILITY PLATESNGZ2009-06-04
1364601626153613K083606SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATESJWY2009-03-24
1364601346030003K081520SENSITITRE VIZIONJWY2008-10-24
1364601099001318K081063SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICSNGZ2009-03-06
1364601826966749K073653SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATEJWY2008-03-20
1364601885024100K073558SENSITITRE 18-24 SUSCEPTIBILITY PLATEJWY2008-03-13
1364601363304049K073424SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATESJWY2008-01-22
1364601617067656K060783SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVALJWY2006-05-16
1364601809930141K060621SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015-JWY2006-04-21
1364601480071914K052091SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICSJWY2005-09-21
1364601039128082K040846SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATESJWY2004-04-26
1364601707962431K040619SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATESJWY2004-04-07
1364601507062033K033522SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATESJWY2004-02-03
1364602000038044K031545SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATEJWY2003-07-16
1364601432453485K024353SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATESLTT2003-03-06
1364601942925157K020859CEFOTAXIMEJWY2002-05-15
1364601819806811K013368HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATELTT2001-11-20
1364601250090572K012921SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATEJWY2001-11-02
1364602011268015K012895HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAEJWY2001-10-30
76421587487124K012588OXOID PYLORI TEST KIT, MODEL DR0130MLYR2001-12-10
1364601148557823K012151HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATEJWY2001-08-29
1364601760741266K011803SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATESJWY2001-08-15
76421393143424K011710OXOID PBP2 1 LATEX AGGLUTINATION TESTMYI2002-04-02
1364601738272982K003868SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICSJWY2001-02-27
1364601969376951K001558SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN)JWY2000-07-24
1364601401939904K001036SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN)JWY2000-06-06
1364601567679537K001035SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN)JWY2000-05-23
76421000825844

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
JWY652025-06-30
NGZ52023-08-31
GTZ51991-03-29
GTJ51986-02-04
LRG42019-11-06
LTT32003-03-06
LIE22011-06-22
LKT21999-03-18
GMZ21998-04-23
GNA21996-11-01
JTO21990-06-01
LJP21990-04-16
DDC21978-06-14
MYI12002-04-02
LYR12001-12-10
JTW11998-11-30
LQL11998-01-22
JWX11995-06-01
DAP11992-01-31
GQL11990-12-13
GNB11990-01-11
LQM11989-06-09
GRM11989-02-16
KTN11988-04-07
JSM11987-04-20
LIO11986-08-04
GTN11985-05-22
GWC11984-05-02
GRD11984-01-10
GMQ11982-09-21
JTZ11980-12-22