FDA UDI
In Commercial Distribution
🇺🇸 United States
Noble Dip Card with AD (Urine)
DI: 10858886006602
·
Model: E-NMCardA-05-18-BT
·
NOBLE MEDICAL INC
Product Codes
5
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- Noble Dip Card with AD (Urine)
- Primary DI
- 10858886006602
- Version / Model
- E-NMCardA-05-18-BT
- Company Name
- NOBLE MEDICAL INC
- Labeler DUNS
- 035967806
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2022-04-28
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- e47e5902-681f-4156-8c38-a59d9e8c2678
- Distribution End Date
- 2080-04-28
Device Description
AMP1000/COC300/OPI2000/PCP25/THC50(pH/OX/SG)
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PUX | Test, Amphetamine, Employment And Insurance Testing, Exempt | Clinical Toxicology | 862.3100 | 2 |
| PVA | Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt | Clinical Toxicology | 862.3250 | 2 |
| PVH | Test, Opiates, Employment And Insurance Testing, Exempt | Clinical Toxicology | 862.3650 | 2 |
| PVJ | Test, Cannabinoid, Employment And Insurance Testing, Exempt | Clinical Toxicology | 862.3870 | 2 |
| LCM | Enzyme Immunoassay, Phencyclidine | Unknown | U |
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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00858886006605 | GS1 | ||||
| Primary | 10858886006602 | GS1 |