FDA.reportPublic FDA data

DrugCheck

Primary DI
B2983012510
Brand
DrugCheck
Company
Express Diagnostic Int'l, Inc.
Model
30125
Catalog number
30125
Device description
Single Dip Drug Test, MET500
Published
2019-04-08
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
NGGTest, Methamphetamine, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGGTest, Methamphetamine, 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
B2983012510PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Methamphetamine-specific IVD, kit, immunochromatographic test (ICT) assay, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of a specific methamphetamine 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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00311917077932WalgreensWALGREEN CO.NGG2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGG2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGG2026-10-14
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NGG2026-10-13
06942598249406One Step® Methamphetamine (MET500) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGG2026-10-12
10722066005511Rapid ResponseBTNX IncNGG2026-10-09
10722066018979Rapid ResponseBTNX IncNGG2026-10-08
10722066019013Rapid ResponseBTNX IncNGG2026-10-08
10722066019020Rapid ResponseBTNX IncNGG2026-10-08
10722066019037Rapid ResponseBTNX IncNGG2026-10-08
10722066019044Rapid ResponseBTNX IncNGG2026-10-08
10722066018955Rapid ResponseBTNX IncNGG2026-10-06
10722066018696Rapid ResponseBTNX IncNGG2026-09-18
G474M210501EI0mLife Rapid Drug TestMlife Diagnostics, LLCNGG2026-08-14
06936983113939Alltest MDMA500 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983113946Alltest MET500 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983114080Alltest MDMA500 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983114097Alltest MET500 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983114172Alltest MDMA500 Rapid Test Dipstick(Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983114257Alltest MET500 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983114363Alltest MDMA500 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983114370Alltest MET500 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983114516Alltest MDMA500 Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983114523Alltest MET500 Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983114660Alltest MDMA500 Home Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983114677Alltest MET500 Home Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983114684Alltest MET500 Home Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-16
16936983138632Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGG2026-04-16