FDA UDI
In Commercial Distribution
🇺🇸 United States
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR200
DI: 10796918001358
·
Model: 03-3916
·
ALFA SCIENTIFIC DESIGNS, INC.
Product Codes
10
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR200
- Primary DI
- 10796918001358
- Version / Model
- 03-3916
- Company Name
- ALFA SCIENTIFIC DESIGNS, INC.
- Labeler DUNS
- 176391167
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2019-05-02
- Public Version Status
- Update
- Public Device Record Key
- 5cd1bf1f-350e-461d-b125-1386bde93957
Device Description
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR2000, MTD, PCP, PPX, THC
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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 |
| JXN | Enzyme Immunoassay, Propoxyphene | Clinical Toxicology | 862.3700 | 2 |
| LCM | Enzyme Immunoassay, Phencyclidine | Unknown | U | |
| DJR | Enzyme Immunoassay, Methadone | Clinical Toxicology | 862.3620 | 2 |
| 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 |
| JXM | Enzyme Immunoassay, Benzodiazepine | Clinical Toxicology | 862.3170 | 2 |
| DIS | Enzyme Immunoassay, Barbiturate | Clinical Toxicology | 862.3150 | 2 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | 862.3100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46996 | Proctological operating table, hydraulic | A mobile table powered by manually-operated hydraulic mechanisms designed to support a patient during proctological procedures (i.e., diagnosis and treatment of the colon, rectum, anus, and/or the perineum). Its surface consists of sections that can be height-adjusted in relation to the section that supports the patient's trunk and the section supporting the knees (the patient is usually in a kneeling position to provide the surgeon with posterior access). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10796918001358 | GS1 | ||||
| Unit of Use | 00796918001351 | GS1 |