FDA UDI In Commercial Distribution 🇺🇸 United States

Accutest CLEAR Cocaine Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit

DI: 10763924314918 · Model: DS314 · JANT PHARMACAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25

Basic Information

Brand Name
Accutest CLEAR Cocaine Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit
Primary DI
10763924314918
Version / Model
DS314
Company Name
JANT PHARMACAL CORPORATION
Labeler DUNS
797393659
Distribution Status
In Commercial Distribution
Device Count in Pkg
25
Record Status
Published
Publish Date
2016-09-20
Public Version
3
Public Version Date
2022-06-10
Public Version Status
Update
Public Device Record Key
c4a0015d-9c28-419a-851b-249a6a9a5673

Device Description

Accutest CLEAR Cocaine Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
Yes
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
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

GMDN Terms

Code Name
30520 Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical

Identifiers

Type ID
Primary 10763924314918
Unit of Use 00763924314911