FDA.reportPublic FDA data

DrugCheck

Primary DI
B298302250
Brand
DrugCheck
Company
Express Diagnostic Int'l, Inc.
Model
30225
Catalog number
30225
Device description
DrugCheck Dip Drug Test, COC150-THC20
Published
2019-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDJEnzyme Immunoassay, Cannabinoids
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2
NFYTest, Cocaine And Cocaine Metabolites, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171695000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171695000First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test MarijuanaW.H.P.M., Inc.2018-02-05NFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B298302250PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

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
B29830140C10DrugCheck30140C30140C2019-04-23
B2986050010DrugCheck60500605002019-04-25
B2986102010DrugCheck61020610202019-04-12
B298705420DrugCheck70542705422026-04-03
B29830142C0DrugCheck30142C30142C2022-01-10
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
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
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035554Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035707Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10722066015053Rapid ResponseBTNX IncNFY2026-05-15
10722066015084Rapid ResponseBTNX IncNFY2026-05-15
10722066011260Rapid ResponseBTNX IncNFY2026-01-19
10722066011277Rapid ResponseBTNX IncNFY2026-01-19
10722066009083Rapid ResponseBTNX IncNFY2025-10-03
10722066010973Rapid ResponseBTNX IncNFY2025-07-08
10722066009076Rapid ResponseBTNX IncNFY2025-03-28
10722066008291Rapid ResponseBTNX IncNFY2024-08-15
10722066009014Rapid ResponseBTNX IncNFY2024-08-15
10722066008345Rapid Response BTNX IncNFY2024-08-15
10722066008611Rapid ResponseBTNX IncNFY2024-08-14
10722066008857Rapid ResponseBTNX IncNFY2024-08-14
10722066007409Rapid ResponseBTNX IncNFY2024-04-01
10722066007942Rapid ResponseBTNX IncNFY2024-04-01
10722066007959Rapid ResponseBTNX IncNFY2024-04-01
10722066008055Rapid ResponseBTNX IncNFY2024-04-01
10722066008093Rapid ResponseBTNX IncNFY2024-04-01
10722066008123Rapid ResponseBTNX IncNFY2024-04-01
10722066008253Rapid Response BTNX IncNFY2024-04-01