FDA UDI
In Commercial Distribution
🇺🇸 United States
ACCUTEST - 5 Drug Test Cup *CLIA-Waived*
DI: 10763924086532
·
Model: DS86S625
·
JANT PHARMACAL CORPORATION
Product Codes
5
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- ACCUTEST - 5 Drug Test Cup *CLIA-Waived*
- Primary DI
- 10763924086532
- Version / Model
- DS86S625
- Company Name
- JANT PHARMACAL CORPORATION
- Labeler DUNS
- 797393659
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 5
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- bf31ff2a-fafa-44a9-a028-ba6de36ad59c
Device Description
ACCUTEST - 5 Drug Test Cup *CLIA-Waived* AMP (1000), COC (300), OPI (2000), PCP (25), and THC (50)
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 |
|---|---|---|---|---|
| LCM | Enzyme Immunoassay, Phencyclidine | Unknown | U | |
| LFH | U.V. Spectrometry, Tricyclic Antidepressant Drugs | Clinical Toxicology | 862.3910 | 2 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | 862.3250 | 2 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | 862.3100 | 2 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | 862.3650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46994 | Multiple drugs of abuse 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 of abuse 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 | 10763924086532 | GS1 | ||||
| Unit of Use | 00763924086535 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071489 | 000 |