FDA.reportPublic FDA data

Nathan Hardesty

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96150373003261083Nathan Hardesty1N2026-01-01595 Anglum Rd Bldg 1, 2nd Flr. Hazelwood MO US 63042
96157543008237827Nathan Hardesty1N2026-01-01595 Anglum Rd Bldg. 1, 2nd Flr. Hazelwood MO US 63042
96157553007808629Nathan Hardesty1N2026-01-01595 Anglum Rd Bldg 1, 2nd Floor Hazelwood MO US 63042
30082499223008249922Nathan Hardesty1N2026-01-01595 Anglum Rd Bldg. 1, 2nd Flr Hazelwood MO US 63042
30093075983009307598Nathan Hardesty1N2026-01-01595 Anglum Rd Bldg. 1, 2nd Flr. Hazelwood MO US 63042
30100994343010099434Nathan Hardesty1N2026-01-01595 Anglum Rd Hazelwood MO US 63042
30133949413013394941Nathan Hardesty1N2026-01-01595 Anglum Rd Bldg. 1, 2nd Flr. Hazelwood MO US 63042

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1132241074675592P120014BIOMERIEUX THXID BRAF ASSAY KITOWD2013-05-29
97621047790559K992993ETEST FOR QUINUPRISTIN/DALFOPRISTINLTX1999-11-16
97621991472259K990722ETEST FOR CEFUROXIMEJWY1999-04-22
97621709348519K990297ETEST MINOCYCLINEJWY1999-03-22
97621769142822K983027TRIMETHOPRIM/SULPHAMETHOXAZOLEJWY1998-10-02
97621151636697K982868ETEST RIFAMPICIN WITH INDICATIONS FOR S. PNEUMONIAEJWY1998-09-30
97621145803955K981139ETEST CEFTRIAXONEJWY1998-06-01
97621814732467K981138ETEST CIPROFLOXACINJWY1998-06-05
97621739616353K981137ETEST CEFOTAXIMEJWY1998-06-09
97621427392458K981136ETEST FOSFOMYCINJWY1998-06-09
97621905593043K981135ETEST BENZYLPENICILLINJWY1998-06-09
97621920499570K981134ETEST TETRACYCLINEJWY1998-05-28
97622020091081K980348ETEST VANCOMYCINJWY1998-05-29
97621780085862K980345ETEST CEFTRIAXONEJWY1998-05-27
97621264994980K980342ETEST CHLORAMPHENICALJWY1998-05-29
97621453900822K980338ETEST OFLOXACINJWY1998-05-28
97621978991899K971697ETEST FOR LEVOFLOXACINJWY1997-07-14
97621695768081K971694ETEST FOR CEFTAZIDIMEJWY1997-06-30
97621102171800K970473ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAEJWY1997-05-01
97621615278985K970210AMIKACINJWY1997-05-01
97622040602910K964203PIPERACILLIN/TAZOBACTAM 4JWY1996-12-18
97621693424160K963107ETEST FOR CEFEPIMEJWY1996-10-24
97621439008952K962794ETEST FOR AZTREONAMJWY1996-08-30
97621340543445K961519ETEST SUBMISSION FOR AZITHROMYCINJWY1996-07-05
97621439548773K961517ETEST SUBMISSION FOR CEFOTETANJWY1996-07-05
97621484640792K960991ETEST SUBMISSION FOR AMOXICILLINJWY1996-10-08
97621945427109K960989ETEST SUBMISSION FOR IMIPENEMJWY1996-05-20
97621888053662K955920THE E TEST CEFTIZOXIMEJWY1996-02-22
97621334815790K953223PIPERACILIN TAZOBACTAM 4 UGJWY1995-08-15
97621636371585K951879TICARCILLIN/CLAVULANIC ACID 2JWY1995-07-07
97621003271432K950328AMOXICILLIN/CLAVULANIC ACID 2/1JWY1995-04-14
97621866906169K946364E TEST FOR OFLOXACINJWY1995-05-02
97621963799493K945433ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUSJWY1995-03-17
97622024019817K935519ETEST FOR AMPICILLIN/SULBACTAM 2/1JWY1994-11-04
97601808495193K923579MINIVIDAS INSTRUMENTJJE1993-02-12
97621808495193K923579MINIVIDAS INSTRUMENTJJE1993-02-12
97621382785368K913459THE E TEST, MODIFICATIONJWY1991-09-25
97622035124959K910304RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIALQL1991-07-26
97601689820147K891385VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)DEW1989-04-18
97621689820147K891385VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)DEW1989-04-18
97621060592356K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)JWY2026-04-21
97621844204550K250856ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)JWY2025-06-12
97621355881271K250274ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)JWY2025-04-30
97621404246335K232395ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUDJWY2023-10-05
97621955519805K212461VITEK MS PRIMEQBN2022-03-15
97621375712980K210757ETEST Fosfomycin (FO) (0.032-512 µg/mL)JWY2021-11-12
97621663424570K200512ETEST Plazomicin (PLZ) (0.016-256 µg/mL)JWY2020-05-07
97621192737158K192738ETEST Delafloxacin (DFX) (0.002-32 µg/mL)JWY2019-11-26
97621709209715K192050ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)JWY2019-09-27
97621339031084K191953ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)JWY2019-08-22
97621578543520K190154ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)JWY2019-05-01
97621683691697K183031ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)JWY2019-01-11
97621021809147K181412VITEK MSQBN2018-12-21
97611317963395K181092CHROMID CARBA agar (CARB)JSO2018-07-06
3056461317963395K181092CHROMID CARBA agar (CARB)JSO2018-07-06
97621539421213K180936ETEST Telavancin (TLA) (0.002-32 ug/mL)JWY2018-07-03
97621452655697K172150Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)JWY2017-09-15
97621999161146K170670Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)JWY2017-05-31
97611072208669K163042chromID Strepto B agarPQZ2017-01-27
97621076966828K162950VITEK MSPEX2017-07-22
97621004075417K162385RAPIDEC CARBA NPPTJ2017-04-27
1302861479660502K162076chromID MRSAJSO2016-10-25
97621385400763K151873Etest Ceftaroline (0.002 - 32ug/ml)JWY2015-10-07
97611976518095K151688chromID MRSAJSO2016-03-11
1302861976518095K151688chromID MRSAJSO2016-03-11
97601256878460K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion IILYR2015-07-09
97622025377233K121002ETEST CEFTAROLINEJWY2012-10-12
97621319233672K102668ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/MLJWY2010-11-17
97621910999416K093604ETEST MOXIFLOXACIN 0.002-32 UG/MLJWY2010-08-25
97611585624438K091025CHROMID VRE AGAR, MODEL: REF 43 851JSO2010-03-02
3056461585624438K091025CHROMID VRE AGAR, MODEL: REF 43 851JSO2010-03-02
97611859216311K091024CHROMID MRSA AGAR, MODEL: REF 43 841JSO2009-07-17
97621391237231K082534ETEST VORICONAZOLE 0.002-32 UG/MLNGZ2009-11-02
97622055472191K081325ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/MLJWY2008-07-24
97622033127154K052366ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIAJWY2005-10-13
97621178765023K042392DAPTOMYCINJWY2004-12-13
97621852297672K042390ETEST FOR GEMIFLOXACINJWY2004-11-19
97622002566382K040560ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTINGNGZ2004-07-27
97621977961215K020748ETEST ERTAPENEMJWY2002-04-29
97621920817646K010363ETEST MEROPENEMJWY2001-04-09
97621809966640K002139ETEST LINEZOLIDLTX2000-11-08
97621995583729K001547ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIPJWY2000-08-07
97621791175444K000596ETEST GATIFLOXACINJWY2000-05-22
97621130241690K000298ETEST MOXIFLOXACINJWY2000-05-18
97621301260354DEN130013VITEK MSPEX2013-08-21
1768321880727777DEN130013VITEK MSPEX2013-08-21
97611726908995
1302861726908995
97612030118068
1302862030118068
97611153933171
97621153933171
1302861153933171
1132241273471707
1132241309172281
97621364985358
1132241400556961
97621449478608
97621556508340
97611561952198
97621639263523
97621661761539
97601672712841
97621672712841
3056461726908995
97621771588222
97611783167227
1302861783167227
97611850580972
1302861850580972
97621869335524
97621901555747
97601955519805
97611965993282
97621965993282
97612006039483
97612019872547

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWY602026-04-21
JSO82018-07-06
PEX42017-07-22
QBN22022-03-15
NGZ22009-11-02
LTX22000-11-08
JJE21993-02-12
DEW21989-04-18
PTJ12017-04-27
PQZ12017-01-27
LYR12015-07-09
OWD12013-05-29
LQL11991-07-26