FDA UDI
In Commercial Distribution
🇺🇸 United States
DrugConfirm Advanced™ 6 Panel Instant Drug Test
DI: 00895330002073
·
Model: 03-5542
·
CONFIRM BIOSCIENCES, INC.
Product Codes
6
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DrugConfirm Advanced™ 6 Panel Instant Drug Test
- Primary DI
- 00895330002073
- Version / Model
- 03-5542
- Company Name
- CONFIRM BIOSCIENCES, INC.
- Labeler DUNS
- 806524968
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-06
- Public Version
- 4
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 44c4c0ed-f30f-4836-b495-455a679cdf9f
Device Description
This kit tests for: Cocaine (COC), Marijuana (THC), Opiates (OPI), Methamphetamines (mAMP), Amphetamines (AMP), Phencyclidine (PCP)
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 |
|---|---|---|---|---|
| DKE | Reagents, Test, Tetrahydrocannabinol | Clinical Toxicology | 862.3870 | 2 |
| LCM | Enzyme Immunoassay, Phencyclidine | Unknown | U | |
| DOE | Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. | Clinical Toxicology | 862.3640 | 2 |
| DJC | Thin Layer Chromatography, Methamphetamine | Clinical Toxicology | 862.3610 | 2 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | 862.3250 | 2 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | 862.3100 | 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 | 00895330002073 | GS1 |