FDA UDI
In Commercial Distribution
🇺🇸 United States
VeriQuick
DI: 00049696708319
·
Model: 11012637M
·
FOURSTAR GROUP INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VeriQuick
- Primary DI
- 00049696708319
- Version / Model
- 11012637M
- Company Name
- FOURSTAR GROUP INC.
- Labeler DUNS
- 656091279
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-27
- Public Version
- 1
- Public Version Date
- 2023-07-05
- Public Version Status
- New
- Public Device Record Key
- 2d627f59-915a-458d-ae61-1bbbdd5719c9
Device Description
AT HOME MULTI-DRUG TEST
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | 862.3250 | 2 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | 862.3650 | 2 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | 862.3100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55525 | Benzodiazepine group IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple benzodiazepines in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00049696708319 | GS1 |