FDA.reportPublic FDA data

DrugCheck

Primary DI
B2983052110
Brand
DrugCheck
Company
Express Diagnostic Int'l, Inc.
Model
30521
Catalog number
30521
Device description
5 Panel Dip Drug Test, AMP500-COC150-MET500-OPI300-THC
Published
2019-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B2983052110PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B2986074060DrugCheck60740-660740-62026-03-09
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
B298606220DrugCheck 60622606222025-12-09
B298305250DrugCheck 30525305002023-11-30
B2986089051DrugCheck 60890-560890-52023-11-28
B2987050030DrugCheck 70500-370500-32023-08-28
B298606190DrugCheck60619606192023-04-14
B298608040DrugCheck60804608042022-10-14
B29880408EI0DrugCheck80408-EI80408-EI2022-10-12
B298605090DrugCheck60509605092022-07-27
B298607260DrugCheck60726607262022-07-22
B298610700DrugCheck61070610702022-07-22
B29830128C10DrugCheck30128C30128C2019-05-31
B298309130DrugCheck30913309132022-03-02
B29880628EI0DrugCheck80628-EI80628-EI2022-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
80810164510736Atida Marijuana (THC) Drug of Abuse Strip Test RxACESO LABORATORIES INC.LDJ2026-03-23
M90107RD7205060QuickProfile™ Drugs of Abuse Test CupLUMIQUICK DIAGNOSTICS, INC.LDJ2026-03-11
M90107RD7205030QuickProfile™ Drugs of Abuse Test CupLUMIQUICK DIAGNOSTICS, INC.LDJ2026-03-10
M90107RD7205040QuickProfile™ Drugs of Abuse Test CupLUMIQUICK DIAGNOSTICS, INC.LDJ2026-03-10
B2986074060DrugCheckExpress Diagnostic Int'l, Inc.LDJ2026-03-09
00850013035786Identify Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2025-12-04
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00850013035816Identify Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCLDJ2025-12-04
00850013035823Identify Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCLDJ2025-12-04
00812203030872DrugSmartCHEMTRON BIOTECH INCLDJ2025-09-26
00850721007334Identify Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCLDJ2025-09-11
00850721007204Identify Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2025-09-11
10810038638093Easy@Home Marijuana Test Strip(THC 20)EASY HEALTHCARE CORPORATIONLDJ2025-07-10
10816862027324Prime ScreenWONDFO USA CO., LTD.LDJ2025-07-03
26952804810461Marijuana Test StripASSURE TECH. (HANGZHOU) CO., LTD.LDJ2025-03-18
10815845024299SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.LDJ2024-12-17
00049696712675VeriQuickFOURSTAR GROUP INC.LDJ2024-12-05
06972412611966LyherHangzhou Laihe Biotech Co.,Ltd.LDJ2024-11-12
06972412619696LyherHangzhou Laihe Biotech Co.,Ltd.LDJ2024-11-12
10810038636990Areta Multi-Drug Test Cup (25 tests kit)EASY HEALTHCARE CORPORATIONLDJ2024-09-30
40810038636434Easy@Home Multi-Drug Screen Test (5 tests kit)EASY HEALTHCARE CORPORATIONLDJ2024-07-17
00812203030773Premier BiotechCHEMTRON BIOTECH INCLDJ2024-05-28
00722066008362Rapid ResponseBTNX IncLDJ2024-02-26
00812203030681GenericCHEMTRON BIOTECH INCLDJ2024-02-05
00850040879162Number 1DEUS VULT, LLCLDJ2024-02-01
10810124273092SureStepTM Urine Test Drug Screen Strip, Marijuana (THC 50)ALERE SAN DIEGO, INC.LDJ2023-12-15
10810124273337SureStepTM Urine Drug Test CassetteALERE SAN DIEGO, INC.LDJ2023-12-15
10810124273788CERTUM THC One Step Marijuana Test StripALERE SAN DIEGO, INC.LDJ2023-12-15
00850013035502Identify Health MEDICAL DISTRIBUTION GROUP INCLDJ2023-12-07
10816862023760Prime ScreenWONDFO USA CO., LTD.LDJ2023-08-03