FDA UDI
In Commercial Distribution
🇺🇸 United States
Alltest EDDP300 Rapid Test Dipstick (Urine)-CLIA Waived
DI: 06936983114288
·
Model: 1
·
Hangzhou AllTest Biotech Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
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Basic Information
- Brand Name
- Alltest EDDP300 Rapid Test Dipstick (Urine)-CLIA Waived
- Primary DI
- 06936983114288
- Version / Model
- 1
- Catalog Number
- DED-A101C (300ng)
- Company Name
- Hangzhou AllTest Biotech Co., Ltd.
- Labeler DUNS
- 543254717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2026-04-21
- Public Version
- 1
- Public Version Date
- 2026-04-29
- Public Version Status
- New
- Public Device Record Key
- 9ed269eb-d256-4d00-b310-e09a4183a310
Device Description
50T, for FDA CLIA Waived
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| PTG | Test, Methadone, Over The Counter | Clinical Toxicology | 862.3620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42656 | 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 86936983114284 | GS1 | ||||
| Primary | 06936983114288 | GS1 |