FDA.reportPublic FDA data

DrugCheck

Primary DI
B29880140EI0
Brand
DrugCheck
Company
Express Diagnostic Int'l, Inc.
Model
80140-EI
Catalog number
80140-EI
Device description
DrugCheck SalivaScan Oral Fluid Drug Test - THC
Published
2020-03-10
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
PVJTest, Cannabinoid, Employment And Insurance Testing, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PVJTest, Cannabinoid, Employment And Insurance Testing, ExemptClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B29880140EI0PrimaryHIBCC0

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 Temperature2 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
Premarket exempt
true
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVJ2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVJ2026-04-29
B29880502EI0DrugCheck Express Diagnostic Int'l, Inc.PVJ2026-02-20
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVJ2026-01-29
00810174470963PRIME SCREEN®WONDFO USA CO., LTD.PVJ2025-12-05
00810174471007PRIME SCREEN®WONDFO USA CO., LTD.PVJ2025-12-05
00810174471182SAFElife™WONDFO USA CO., LTD.PVJ2025-12-05
00810174471212PRIME SCREEN®WONDFO USA CO., LTD.PVJ2025-12-05
00810174471144PRIME SCREEN®WONDFO USA CO., LTD.PVJ2025-12-03
00810174471168PRIME SCREEN®WONDFO USA CO., LTD.PVJ2025-12-03
G474M3209010VerifyMlife Diagnostics, LLCPVJ2025-09-05
G474M3208010VerifyMlife Diagnostics, LLCPVJ2025-07-21
00816862026634Prime ScreenWONDFO USA CO., LTD.PVJ2025-07-03
G474M3106010ClassicMlife Diagnostics, LLCPVJ2025-06-20
G474MC002080001EI0ClassicMlife Diagnostics, LLCPVJ2025-03-19
06977469280080U-Catch Marijuana Multi-Level Drug Test Card(Colloidal Gold)Eterbio, Inc.PVJ2024-12-18
06977469280219S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold)Eterbio, Inc.PVJ2024-12-18
G474MC001050002EI0ClassicMlife Diagnostics, LLCPVJ2024-11-05
G474MV002110001EI0VerifyMlife Diagnostics, LLCPVJ2024-10-08
00850054867704AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-30
00850054867711AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-30
00850054867728AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-30
00850054867735AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-30
00850054867896AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-29
00850054867964AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-29
00850054867773AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-29
00850054867797AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-29
00850054867803AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-29
00383173000252MGC HEALTHGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-27
00850054867100AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-27