FDA UDI
In Commercial Distribution
🇺🇸 United States
Accutest CLEAR MDMA Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit
DI: 10763924320919
·
Model: DS320
·
JANT PHARMACAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- Accutest CLEAR MDMA Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit
- Primary DI
- 10763924320919
- Version / Model
- DS320
- 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
- 5
- Public Version Date
- 2022-12-20
- Public Version Status
- Update
- Public Device Record Key
- f833a573-6145-489f-8bb8-e5ce24653c99
Device Description
Accutest CLEAR MDMA 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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DJC | Thin Layer Chromatography, Methamphetamine | Clinical Toxicology | 862.3610 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55489 | Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs belonging to the amphetamine and/or methamphetamine group(s) [e.g., 3,4-methylenedioxymethamphetamine (MDMA), also known as ecstasy] in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10763924320919 | GS1 | ||||
| Unit of Use | 00763924320912 | GS1 |