FDA.reportPublic FDA data

DrugCheck

Primary DI
B29880628EI0
Brand
DrugCheck
Company
Express Diagnostic Int'l, Inc.
Model
80628-EI
Catalog number
80628-EI
Device description
DrugCheck SalivaScan Oral Fluid Drug Test, AMP-BAR-COC-MET-OPI-PCP
Published
2022-03-01
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
PUXTest, Amphetamine, Employment And Insurance Testing, Exempt
PUYTest, Barbiturate, Employment And Insurance Testing, Exempt
PVATest, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt
PVCTest, Lsd, Employment And Insurance Testing, Exempt
PVDTest, Methamphetamine, Employment And Insurance Testing, Exempt
PVHTest, Opiates, Employment And Insurance Testing, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUXTest, Amphetamine, Employment And Insurance Testing, ExemptClinical Toxicology2
PUYTest, Barbiturate, Employment And Insurance Testing, ExemptClinical Toxicology2
PVATest, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, ExemptClinical Toxicology2
PVCTest, Lsd, Employment And Insurance Testing, ExemptClinical Toxicology2
PVDTest, Methamphetamine, Employment And Insurance Testing, ExemptClinical Toxicology2
PVHTest, Opiates, Employment And Insurance Testing, ExemptClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B29880628EI0PrimaryHIBCC0

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 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. It is not intended to be used for self-testing.

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, LLCPUX2026-04-29
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVA2026-04-29
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVD2026-04-29
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVH2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPUX2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVA2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVH2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVD2026-04-29
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPVD2026-04-03
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPVA2026-04-03
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPVH2026-04-03
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPUX2026-04-03
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVA2026-01-29
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVD2026-01-29
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVH2026-01-29
G474M3209010VerifyMlife Diagnostics, LLCPUY2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPVC2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPVH2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPVD2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPVA2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPUX2025-09-05
G474M3208010VerifyMlife Diagnostics, LLCPUY2025-07-21
G474M3208010VerifyMlife Diagnostics, LLCPVC2025-07-21
G474M3208010VerifyMlife Diagnostics, LLCPVH2025-07-21
G474M3208010VerifyMlife Diagnostics, LLCPVD2025-07-21
G474M3208010VerifyMlife Diagnostics, LLCPVA2025-07-21
G474M3208010VerifyMlife Diagnostics, LLCPUX2025-07-21
G474M3106010ClassicMlife Diagnostics, LLCPVA2025-06-20
G474M3106010ClassicMlife Diagnostics, LLCPVD2025-06-20
G474M3106010ClassicMlife Diagnostics, LLCPVH2025-06-20