Alltest EDDP300 Rapid Test Dipstick (Urine)-CLIA Waived
- Primary DI
- 06936983114288
- Brand
- Alltest EDDP300 Rapid Test Dipstick (Urine)-CLIA Waived
- Company
- Hangzhou AllTest Biotech Co., Ltd.
- Model
- 1
- Catalog number
- DED-A101C (300ng)
- Device description
- 50T, for FDA CLIA Waived
- Published
- 2026-04-21
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| PTG | Test, Methadone, Over The Counter |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| PTG | Test, Methadone, Over The Counter | Clinical Toxicology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K182738 | 000 |
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| K182738 | 000 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2019-03-27 | DKZ |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 06936983114288 | Primary | GS1 | 0 | |
| 86936983114284 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 06936983114288 | 06936983114288 | 6936983114288 |
| 86936983114284 | 86936983114284 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Regulatory Flags#
- DUNS number
- 543254717
- Device count
- 50
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- 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
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 16936983131633 | Multi-Drug Rapid Test Panel (Urine) | 1 | DOA-A1104C | 2026-04-16 |
| 16936983131640 | Multi-Drug Rapid Test Panel (Urine) | 1 | DOA-A1124C | 2026-04-16 |
| 16936983138632 | Multi-Drug 12 Drugs Rapid Test Cup | 1 | DOA-A1127C-062-b-A3 | 2026-04-16 |
| 16936983141120 | Discover Multi-Drug 12 Drugs Rapid Test Cup | 1 | DUA-A1127C-A3 | 2026-04-16 |
| 16936983141137 | Discover Multi-Drug 12 Drugs Rapid Test Cup | 1 | DUA-A1127C-A3 | 2026-04-16 |
| 16936983144664 | Discover | DISP-CUP164N$ | 2023-11-30 | |
| 16936983144671 | Discover | DISP-DUD6144N$ | 2023-11-30 | |
| 16936983144688 | Discover Multi-Drug 10 Drugs Rapid Test Cup (Urine) | 1 | DOA-A1107C-A3 | 2026-04-16 |
| 16936983149744 | Discover milti-drug 7 drugs rapid test cup | DUA-A177C-A3 A1617 | DISP-DUD774N$ | 2024-02-08 |
| 16936983153819 | Discover Multi-Drug 13 Drugs Rapid Test Cup (Urine) | 1 | DUA-A1137C-A3 | 2026-04-15 |
| 16936983165379 | Discover Multi-Drug 5 Drugs Rapid Test Cup(Urine) | 1 | DUA-A157C-A3 | 2026-04-15 |
| 16936983169599 | Alltest Multi-Drug Rapid Urine Test Panel | 1 | DOA-A1144C-026-b | 2026-04-15 |
| 16936983169605 | Alltest Multi-Drug Rapid Urine Test Panel | 1 | DUA-A1144C-003-b | 2026-04-15 |
| 16936983169865 | Discover Multi-Drug 6 Drugs Rapid Test Cup (Urine) | 1 | DUA-A167C-A3 | 2026-04-15 |
| 16936983169872 | Discover Multi-Drug 8 Drugs Rapid Test Cup (Urine) | 1 | DUA-A187C-A3 | 2026-04-15 |
| 16936983170007 | Alltest Multi-Drug 12 Drugs Urine Test Panel | 1 | DOA-A1124C | 2026-04-15 |
| 16936983170014 | Alltest Multi-Drug 13 Drugs Urine Test Panel | 1 | DOA-A1134C | 2026-04-15 |
| 16936983170021 | Alltest Multi-Drug 14 Drugs Urine Test Panel | 1 | DOA-A1144C | 2026-04-15 |
| 16936983170038 | Alltest Multi-Drug 14 Drugs Urine Test Panel | 1 | DOA-A1144C | 2026-04-15 |
| 16936983171998 | Alltest Multi-Drug 13 Drugs Rapid Urine Test Panel | 1 | DOA-A1134C | 2026-04-15 |
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| 10722066018696 | Rapid Response | BTNX Inc | PTG | 2026-09-18 |
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| 06936983114073 | Alltest EDDP300 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
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| 06936983114233 | Alltest MTD300 Rapid Test Dipstick (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983114356 | Alltest EDDP300 Rapid Test Panel (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983114387 | Alltest MTD300 Rapid Test Panel (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983114479 | Alltest EDDP300 Home Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983114530 | Alltest MTD300 Home Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983114622 | Alltest EDDP300 Home Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983113922 | Alltest EDDP300 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-17 |
| 16936983131633 | Multi-Drug Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-16 |
| 16936983131640 | Multi-Drug Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-16 |
| 16936983138632 | Multi-Drug 12 Drugs Rapid Test Cup | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-16 |
| 16936983141120 | Discover Multi-Drug 12 Drugs Rapid Test Cup | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-16 |
| 16936983141137 | Discover Multi-Drug 12 Drugs Rapid Test Cup | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-16 |
| 16936983144688 | Discover Multi-Drug 10 Drugs Rapid Test Cup (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-16 |
| 06936983114790 | Alltest Multi-Drug 15 Drugs Rapid Test Panel (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-16 |
| 06936983114806 | Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-16 |
| 06936983114813 | Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-16 |
| 06936983114820 | Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-16 |
| 06936983114837 | Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-16 |
| 06936983114844 | Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-16 |