FDA.reportPublic FDA data

DrugCheck

Primary DI
B2986074060
Brand
DrugCheck
Company
Express Diagnostic Int'l, Inc.
Model
60740-6
Catalog number
60740-6
Device description
DrugCheck NxStep OnSite Drug Test, CLIA Waived, AMP-COC-MET500-OPI300-OXY-PCP-THC-pH,SG,OX-CR,NI,GL
Published
2026-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DJGEnzyme Immunoassay, Opiates
DKZEnzyme Immunoassay, Amphetamine
LCMEnzyme Immunoassay, Phencyclidine
LDJEnzyme Immunoassay, Cannabinoids
NGGTest, Methamphetamine, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2
NGGTest, Methamphetamine, Over The CounterClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B2986074060PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

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
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
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
B298605010DrugCheck 60501605012026-02-19
B298309130DrugCheck30913309132022-03-02
B2986117650DrugCheck61176-561176-52021-05-26
B298611760DrugCheck61176611762021-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G474M210501EI0mLife Rapid Drug TestMlife Diagnostics, LLCNGG2026-08-14
00817405024247iScreen™Instant Technologies, Inc.LDJ2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LCM2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DJG2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DIO2026-08-01
00810173656719HealgenHealgen Scientific Limited Liability CompanyDKZ2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyLDJ2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDIO2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDJG2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyLCM2026-07-31
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500217OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500224OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500231OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500248OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500255OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500262OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500279OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500286OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500293OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500309OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500316OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500323OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500330OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500347OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500354OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500361OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11