FDA UDI
In Commercial Distribution
🇺🇸 United States
Six Panel PreScreen Plus Dip Card (CLIA Waived)
DI: 00851000007151
·
Model: PS-DOA-164
·
MERGERS MARKETING, INC.
Product Codes
6
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Six Panel PreScreen Plus Dip Card (CLIA Waived)
- Primary DI
- 00851000007151
- Version / Model
- PS-DOA-164
- Company Name
- MERGERS MARKETING, INC.
- Labeler DUNS
- 065602744
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-08
- Public Version
- 4
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 95976e32-7343-4d35-bdc9-7bf81619c352
Device Description
Six Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: COC|AMP|MET|THC|OPI|PCP
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LCM | Enzyme Immunoassay, Phencyclidine | Unknown | U | |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | 862.3650 | 2 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | 862.3870 | 2 |
| LAF | Gas Chromatography, Methamphetamine | Clinical Toxicology | 862.3610 | 2 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | 862.3100 | 2 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | 862.3250 | 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 |
|---|---|---|---|---|---|---|
| Package | 20851000007155 | GS1 | Case | 20 | In Commercial Distribution | |
| Package | 10851000007158 | GS1 | Inner Pack | 25 | In Commercial Distribution | |
| Primary | 00851000007151 | GS1 |