MD DugScreen
- Primary DI
- 00850969007622
- Brand
- MD DugScreen
- Company
- MEDICAL DISPOSABLES CORP
- Model
- M-DAM-114
- Device description
- CLIA Waived Amphetamine Test Panel (AMP)
- Published
- 2017-03-31
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| DKZ | Enzyme Immunoassay, Amphetamine |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00850969007622 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00850969007622 | 00850969007622 | 850969007622 | 0850969007622 |
GMDN Terms
| Term | Definition |
|---|
| Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid | A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses. |
Regulatory Flags
- DUNS number
- 961673774
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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