FDA UDI
In Commercial Distribution
🇺🇸 United States
Pointe Methadone Metabolite (EDDP) Reagent Set
DI: 00811727018076
·
Model: 60-MM0380-100
·
POINTE SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pointe Methadone Metabolite (EDDP) Reagent Set
- Primary DI
- 00811727018076
- Version / Model
- 60-MM0380-100
- Catalog Number
- 60-MM0380-100
- Company Name
- POINTE SCIENTIFIC, INC.
- Labeler DUNS
- 045623154
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-25
- Public Version
- 1
- Public Version Date
- 2020-10-05
- Public Version Status
- New
- Public Device Record Key
- 40748fcf-e432-4d3a-a494-78ef4500c6ce
Device Description
Pointe Methadone Metabolite (EDDP) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Methadone Metabolite (EDDP) Reagent Set is an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of methadone metabolite in human urine. The cutoff for both the qualitative and semi-quantitative modes of the assay are 100 ng/mL and 300 ng/mL for methadone metabolite. The assay is designed for prescription use on automated clinical chemistry analyzers.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| DJR | Enzyme Immunoassay, Methadone | Clinical Toxicology | 862.3620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59050 | 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 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 the methadone metabolite 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 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 | 00811727018076 | GS1 |
Customer Contacts
- Phone
- 800-445-9853
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K031797 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius