FDA UDI In Commercial Distribution 🇺🇸 United States

DrugCheck

DI: B298307220 · Model: 30722 · Express Diagnostic Int'l, Inc.
Product Codes
6
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DrugCheck
Primary DI
B298307220
Version / Model
30722
Catalog Number
30722
Company Name
Express Diagnostic Int'l, Inc.
Labeler DUNS
015875273
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-02-19
Public Version
1
Public Version Date
2026-02-27
Public Version Status
New
Public Device Record Key
27d372f6-245d-457d-b511-0753bb686094

Device Description

DrugCheck Dip Drug Test CLIA Waived- AMP500 COC150 MET500 OPI300 OXY PCP THC (25 per box)

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DKZ Enzyme Immunoassay, Amphetamine
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
LAF Gas Chromatography, Methamphetamine
DJG Enzyme Immunoassay, Opiates
LCM Enzyme Immunoassay, Phencyclidine
LDJ Enzyme Immunoassay, Cannabinoids

GMDN Terms

Code Name
46994 Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Identifiers

Type ID
Primary B298307220