FDA.reportPublic FDA data

DrugCheck

Primary DI
B2986117650
Brand
DrugCheck
Company
Express Diagnostic Int'l, Inc.
Model
61176-5
Catalog number
61176-5
Device description
DrugCheck NxStep OnSite Drug Test, AMP-BARB-BUP-BZO-COC-MET-MTD-OPI-OXY-PCP-PPX-pH,SG,OX-CR,NI
Published
2021-05-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DISEnzyme Immunoassay, Barbiturate
DJGEnzyme Immunoassay, Opiates
DJREnzyme Immunoassay, Methadone
DKZEnzyme Immunoassay, Amphetamine
JXMEnzyme Immunoassay, Benzodiazepine
JXNEnzyme Immunoassay, Propoxyphene
LAFGas Chromatography, Methamphetamine
LCMEnzyme Immunoassay, Phencyclidine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DJREnzyme Immunoassay, MethadoneClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
JXNEnzyme Immunoassay, PropoxypheneClinical Toxicology2
LAFGas Chromatography, MethamphetamineClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B2986117650PrimaryHIBCC0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
507-526-3951quality@drugcheck.com

Regulatory Flags#

DUNS number
015875273
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B2986080760DrugCheck60807-660807-62026-09-24
B29881100AEI0DrugCheck81100-A-EI81100-A-EI2026-08-25
B2986093010DrugCheck60930609302019-04-17
B29830140C10DrugCheck30140C30140C2019-04-23
B2986050010DrugCheck60500605002019-04-25
B2986102010DrugCheck61020610202019-04-12
B298705420DrugCheck70542705422026-04-03
B29830142C0DrugCheck30142C30142C2022-01-10
B298302250DrugCheck30225302252019-12-31
B298301150DrugCheck30115301152019-09-27
B2987054210DrugCheck70542705422019-07-01
B2983012510DrugCheck30125301252019-04-08
B2983041810DrugCheck30418304182019-11-18
B2986074060DrugCheck60740-660740-62026-03-09
B29860740610DrugCheck60740-660740-62019-08-27
B29880913EI0DrugCheck 80913-EI80913-EI2026-02-23
B2986051360DrugCheck 60513-660513-62026-02-20
B2987050460DrugCheck 70504-670504-62026-02-20
B29880502EI0DrugCheck 80502-EI80502-EI2026-02-20
B298307220DrugCheck 30722307222026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850076289086Hysen Drug Test CupsHYSEN INC.DJG2026-11-05
10850076289086Hysen Drug Test CupsHYSEN INC.DIO2026-11-05
10850076289086Hysen Drug Test CupsHYSEN INC.JXM2026-11-05
10850076289086Hysen Drug Test CupsHYSEN INC.DIS2026-11-05
10850076289086Hysen Drug Test CupsHYSEN INC.LCM2026-11-05
10850076289086Hysen Drug Test CupsHYSEN INC.DKZ2026-11-05
10850076289086Hysen Drug Test CupsHYSEN INC.DJR2026-11-05
10850013035899Identify HealthMEDICAL DISTRIBUTION GROUP INCDKZ2026-11-04
10850013035899Identify HealthMEDICAL DISTRIBUTION GROUP INCDJR2026-11-04
10850013035899Identify HealthMEDICAL DISTRIBUTION GROUP INCDIO2026-11-04
10850013035899Identify HealthMEDICAL DISTRIBUTION GROUP INCJXM2026-11-04
10850013035899Identify HealthMEDICAL DISTRIBUTION GROUP INCDJG2026-11-04
10850013035899Identify HealthMEDICAL DISTRIBUTION GROUP INCDIS2026-11-04
10850013035899Identify HealthMEDICAL DISTRIBUTION GROUP INCLCM2026-11-04
10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCDIS2026-10-30
10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCDJR2026-10-30
10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCDIO2026-10-30
10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCJXM2026-10-30
10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCDJG2026-10-30
10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCDKZ2026-10-30
10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCLCM2026-10-30
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.LCM2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.LCM2026-10-14
06942598249376One Step® Fentanyl(FYL1) Urine Test PanelHangzhou AllTest Biotech Co., Ltd.DJG2026-10-12
00894175000091QMedix™Diagnostic Automation, Inc.DJG2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.LAF2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.LCM2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.DIO2026-09-30
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyJXN2026-09-28