FDA UDI
In Commercial Distribution
🇺🇸 United States
INSTANT-VIEW Propoxyphene (PPX) Urine Cassette Test
DI: 10796918000207
·
Model: 03-2932
·
ALFA SCIENTIFIC DESIGNS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- INSTANT-VIEW Propoxyphene (PPX) Urine Cassette Test
- Primary DI
- 10796918000207
- Version / Model
- 03-2932
- Company Name
- ALFA SCIENTIFIC DESIGNS, INC.
- Labeler DUNS
- 176391167
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 3
- Public Version Date
- 2019-05-01
- Public Version Status
- Update
- Public Device Record Key
- c75030ee-a47f-48aa-a1ca-1c59004018a0
Device Description
INSTANT-VIEW Propoxyphene (PPX) Urine Cassette Test
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 |
|---|---|---|---|---|
| JXN | Enzyme Immunoassay, Propoxyphene | Clinical Toxicology | 862.3700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55764 | Propoxyphene IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of propoxyphene in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10796918000207 | GS1 | ||||
| Unit of Use | 00796918000200 | GS1 |