Multi-Drug Rapid Test Panel (Urine)
- Primary DI
- 16936983131633
- Brand
- Multi-Drug Rapid Test Panel (Urine)
- Company
- Hangzhou AllTest Biotech Co., Ltd.
- Model
- 1
- Catalog number
- DOA-A1104C
- Device description
- 25T, (for FDA Clia Waived), OPI2000/OXY100/COC300/BAR300/BZO300/AMP1000/MET1000/MTD300/THC50/BUP10
- Published
- 2026-04-16
- 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 |
|---|---|
| NFT | Test, Amphetamine, Over The Counter |
| NFV | Test, Benzodiazepine, Over The Counter |
| NFW | Test, Cannabinoid, Over The Counter |
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter |
| NGG | Test, Methamphetamine, Over The Counter |
| NGL | Test, Opiates, Over The Counter |
| PTG | Test, Methadone, Over The Counter |
| PTH | Test, Barbiturate, Over The Counter |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| NFT | Test, Amphetamine, Over The Counter | Clinical Toxicology | 2 |
| NFV | Test, Benzodiazepine, Over The Counter | Clinical Toxicology | 2 |
| NFW | Test, Cannabinoid, Over The Counter | Clinical Toxicology | 2 |
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter | Clinical Toxicology | 2 |
| NGG | Test, Methamphetamine, Over The Counter | Clinical Toxicology | 2 |
| NGL | Test, Opiates, Over The Counter | Clinical Toxicology | 2 |
| PTG | Test, Methadone, Over The Counter | Clinical Toxicology | 2 |
| PTH | Test, Barbiturate, Over The Counter | Clinical Toxicology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K233019 | 000 |
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| K233019 | 000 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx | Hangzhou AllTest Biotech Co., Ltd. | 2023-12-13 | DKZ |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 16936983131633 | Primary | GS1 | 0 | |
| 06936983131636 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 16936983131633 | 16936983131633 | |
| 06936983131636 | 06936983131636 | 6936983131636 |
GMDN Terms#
| Term | Definition |
|---|---|
| Multiple drugs of abuse IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. |
Regulatory Flags#
- DUNS number
- 543254717
- Device count
- 25
- 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 |
|---|---|---|---|---|
| 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 |
| 16936983172025 | Alltest Multi-Drug 13 Drugs Rapid Urine Test Panel | DOA-A1134C-028 | DOA-A1134C | 2026-04-15 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06936983113939 | Alltest MDMA500 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGG | 2026-04-21 |
| 06936983113946 | Alltest MET500 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGG | 2026-04-21 |
| 06936983113953 | Alltest MOP300 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-04-21 |
| 06936983113960 | Alltest MTD300 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983113977 | Alltest MOP2000 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-04-21 |
| 06936983113984 | Alltest OXY100 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-04-21 |
| 06936983114011 | Alltest THC50 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFW | 2026-04-21 |
| 06936983114028 | Alltest AMP500 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-21 |
| 06936983114035 | Alltest BAR300 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTH | 2026-04-21 |
| 06936983114042 | Alltest BUP10 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-04-21 |
| 06936983114059 | Alltest BZO300 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFV | 2026-04-21 |
| 06936983114066 | Alltest COC150 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFY | 2026-04-21 |
| 06936983114073 | Alltest EDDP300 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983114080 | Alltest MDMA500 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGG | 2026-04-21 |
| 06936983114097 | Alltest MET500 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGG | 2026-04-21 |
| 06936983114103 | Alltest MOP300 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-04-21 |
| 06936983114110 | Alltest MTD300 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983114127 | Alltest MOP2000 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-04-21 |
| 06936983114134 | Alltest OXY100 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-04-21 |
| 06936983114165 | Alltest THC50 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFW | 2026-04-21 |
| 06936983114172 | Alltest MDMA500 Rapid Test Dipstick(Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | NGG | 2026-04-21 |
| 06936983114189 | Alltest BZO300 Rapid Test Dipstick(Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | NFV | 2026-04-21 |
| 06936983114196 | Alltest AMP500 Rapid Test Dipstick (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-21 |
| 06936983114202 | Alltest BUP10 Rapid Test Dipstick (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-04-21 |
| 06936983114219 | Alltest BAR300 Rapid Test Dipstick (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | PTH | 2026-04-21 |
| 06936983114226 | Alltest OXY100 Rapid Test Dipstick (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-04-21 |
| 06936983114233 | Alltest MTD300 Rapid Test Dipstick (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983114240 | Alltest MOP300 Rapid Test Dipstick (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-04-21 |
| 06936983114257 | Alltest MET500 Rapid Test Dipstick (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | NGG | 2026-04-21 |
| 06936983114264 | Alltest THC50 Rapid Test Dipstick (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | NFW | 2026-04-21 |