FDA UDI
In Commercial Distribution
🇺🇸 United States
DrugConfirm
DI: 00856464008409
·
Model: CB-DC-4PanelOTC
·
CONFIRM BIOSCIENCES, INC.
Product Codes
4
GMDN Terms
4
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DrugConfirm
- Primary DI
- 00856464008409
- Version / Model
- CB-DC-4PanelOTC
- Company Name
- CONFIRM BIOSCIENCES, INC.
- Labeler DUNS
- 806524968
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-24
- Public Version
- 2
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- d746974b-8b7d-4165-bb2e-247518de49c5
Device Description
4 Drugs Tested Home Drug Test
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter | Clinical Toxicology | 862.3250 | 2 |
| NGG | Test, Methamphetamine, Over The Counter | Clinical Toxicology | 862.3610 | 2 |
| NGL | Test, Opiates, Over The Counter | Clinical Toxicology | 862.3650 | 2 |
| NFW | Test, Cannabinoid, Over The Counter | Clinical Toxicology | 862.3870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55501 | Methamphetamine-specific IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of a specific methamphetamine in a clinical specimen. | No | Active |
| 55553 | Cannabinoid/cannabinoid metabolite IVD, reagent | A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) in a clinical specimen. | No | Active |
| 55570 | Cocaine/cocaine metabolite IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of cocaine and/or cocaine metabolites in a clinical specimen. | No | Active |
| 55724 | Opiate/opiate metabolite IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of opiate and/or opiate metabolites in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856464008409 | GS1 |