FDA UDI
In Commercial Distribution
🇺🇸 United States
GenaCheck®Fentanyl Urine Test Cassette
DI: 00860008954817
·
Model: N/A
·
Genabio Diagnostics Inc.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- GenaCheck®Fentanyl Urine Test Cassette
- Primary DI
- 00860008954817
- Version / Model
- N/A
- Catalog Number
- RA9-E02525
- Company Name
- Genabio Diagnostics Inc.
- Labeler DUNS
- 118586095
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2025-01-13
- Public Version
- 1
- Public Version Date
- 2025-01-21
- Public Version Status
- New
- Public Device Record Key
- df6a0e32-b857-4756-99e4-396a9bbffe28
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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55461 | Multiple drugs of abuse IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860008954817 | GS1 | ||||
| Unit of Use | 86000895481700 | GS1 |