MEDTOX DIAGNOSTICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10501551050155MEDTOX DIAGNOSTICS, INC.1N2026-01-011238 Anthony Rd BURLINGTON NC US 27215
30041753813004175381MEDTOX DIAGNOSTICS, INC.1N2026-01-011640 NOVA LANE BURLINGTON NC US 27215
30112603543011260354MEDTOX Diagnostics, Inc.1N2026-01-016624 Owens Drive Pleasanton CA US 94588

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
00690286000742MEDTOX® - Positive toxicology urine control used to monitor and validate the performance of Labcorp Fentanyl (nFEN) tests.877-643-5703techservices@medtoxdiagnostics.com
00690286000759PROFILE®-V MEDTOXScan® - A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Tricyclic Antidepressants, Methadone, Barbiturates, and Oxycodone drugs and/or metabolites in human urine.877-643-5703techservices@medtoxdiagnostics.com
00690286000766PROFILE®-V MEDTOXScan® - A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Tricyclic Antidepressants, Methadone, Barbiturates, Oxycodone, and Buprenorphine drugs and/or metabolites in human urine.877-643-5703techservices@medtoxdiagnostics.com
00690286000797Labcorp Fentanyl Urine Visual Test - A lateral flow competitive immunoassay for the rapid qualitative detection of norfentanyl (fentanyl metabolite) in human urine.877-643-5703techservices@medtoxdiagnostics.com
00850024924109Labcorp Comfort Draw - Comfort Draw is a silicone bulb intended to assist with capillary blood collection877-643-5703techservices@medtoxdiagnostics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
291791892676434K992111VERDICT -II OPIATES 2000DJG1999-12-16
291781892676434K992111VERDICT -II OPIATES 2000DJG1999-12-16
291791016474543K982211PROFILE-II MODEL 600582DKE1998-07-29
291781016474543K982211PROFILE-II MODEL 600582DKE1998-07-29
291791680696054K252684Labcorp Fentanyl Urine Visual TestDJG2026-01-29
291781680696054K252684Labcorp Fentanyl Urine Visual TestDJG2026-01-29
2976411235604536K172514Trak Plus Male Fertility Testing SystemPOV2017-11-17
2976411424189816K153683Trak Male Fertility Testing SystemPOV2016-05-16
291781358905064K153474Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm seriesDIF2016-02-23
291791358905064K153474Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm seriesDIF2016-02-23
291791610351207K121122DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROLDIF2012-07-03
291781610351207K121122DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROLDIF2012-07-03
291781246702560K100951MEDTOX BUPRENORPHINE TESTDJG2010-10-18
291791246702560K100951MEDTOX BUPRENORPHINE TESTDJG2010-10-18
291781610895340K100023PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEMDJG2010-04-05
291791610895340K100023PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEMDJG2010-04-05
291781416267854K091454PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEMDJG2009-07-24
291791416267854K091454PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEMDJG2009-07-24
291781244697411K080635MEDTOXSCANDKZ2009-02-13
291791244697411K080635MEDTOXSCANDKZ2009-02-13
291781055961167K060351MEDTOX OXYCODONEDJG2006-05-12
291791055961167K060351MEDTOX OXYCODONEDJG2006-05-12
291791983852846K050394SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDSDKZ2005-10-25
291781983852846K050394SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDSDKZ2005-10-25
291781378222623K033334PROFILE -ERDIS2003-11-10
291791378222623K033334PROFILE -ERDIS2003-11-10
291781035406450K031032VERDICT II, PROFILE IIDJG2003-07-14
291791035406450K031032VERDICT II, PROFILE IIDJG2003-07-14
291791673010800K022141VERDICT-IIDJC2002-07-30
291781673010800K022141VERDICT-IIDJC2002-07-30
291791662119441K020787VERDICT-II PROPOXYPHENEJXN2002-05-02
291781662119441K020787VERDICT-II PROPOXYPHENEJXN2002-05-02
291781907868202K011545VERDICT -II TCA, VERDICT-II MTDLFG2001-06-08
291791907868202K011545VERDICT -II TCA, VERDICT-II MTDLFG2001-06-08
291791644191362K010959VERDICT -II BAR; VERDICT -II BZODIS2001-04-13
291781644191362K010959VERDICT -II BAR; VERDICT -II BZODIS2001-04-13
291781423308150K010564VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZODKZ2001-04-05
291791423308150K010564VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZODKZ2001-04-05
291781279956711K010561VERDICT -II BAR/BZODIS2001-04-05
291791279956711K010561VERDICT -II BAR/BZODIS2001-04-05
291791229753139K010226VERDICT -II METHAMPHETAMINEDJC2001-06-01
291781229753139K010226VERDICT -II METHAMPHETAMINEDJC2001-06-01
291781475170584K010138PROFILE II ERLDJ2001-02-14
291791475170584K010138PROFILE II ERLDJ2001-02-14
291781621374821K003687VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COCDKE2000-12-22
291791621374821K003687VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COCDKE2000-12-22
291781846739685K002776MODIFICATION TO PROFILE -IILCM2000-09-28
291791846739685K002776MODIFICATION TO PROFILE -IILCM2000-09-28
291781042831019K002331PROFILE-ERDIS2001-01-17
291791042831019K002331PROFILE-ERDIS2001-01-17
2976411189281138
291781344451007
291791344451007
2976411647178658
291791647178658
291781647178658
291781802461686
291791802461686
291782021647986
291792021647986

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DJG142026-01-29
DIS82003-11-10
DKZ62009-02-13
DIF42016-02-23
DJC42002-07-30
DKE42000-12-22
POV22017-11-17
JXN22002-05-02
LFG22001-06-08
LDJ22001-02-14
LCM22000-09-28

PMN#

GUDID#

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