Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA Waived
- Primary DI
- 06936983114806
- Brand
- Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA Waived
- Company
- Hangzhou AllTest Biotech Co., Ltd.
- Model
- 1
- Catalog number
- DOA-A1157C-007-b-A1
- Device description
- 25T, for FDA POC, MOP300/MOP2000/MDMA500/OXY100/EDDP300/PCP25/COC150/MTD300/BAR300/BZO300/AMP500/MET500/TCA1000/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
- false
- 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 |
| NGM | Test, Phencyclidine (Pcp), Over The Counter |
| PTG | Test, Methadone, Over The Counter |
| PTH | Test, Barbiturate, Over The Counter |
| QAW | Test, Tricyclic Antidepressants, 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 |
| NGM | Test, Phencyclidine (Pcp), Over The Counter | Unknown | U |
| PTG | Test, Methadone, Over The Counter | Clinical Toxicology | 2 |
| PTH | Test, Barbiturate, Over The Counter | Clinical Toxicology | 2 |
| QAW | Test, Tricyclic Antidepressants, 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 |
|---|---|---|---|---|
| 06936983114806 | Primary | GS1 | 0 | |
| 86936983114802 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 06936983114806 | 06936983114806 | 6936983114806 |
| 86936983114802 | 86936983114802 |
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 |
|---|---|---|---|---|
| 06942598249376 | One Step® Fentanyl(FYL1) Urine Test Panel | 1 | DFY-A114H | 2026-10-12 |
| 06942598249383 | One Step® Buprenorphine (BUP10) Home Rapid Test Dipstick | 1 | DBU-A101H | 2026-10-12 |
| 06942598249390 | One Step® Benzodiazepines (BZO300) Home Rapid Test Dipstick | 1 | DBZ-A101H | 2026-10-12 |
| 06942598249406 | One Step® Methamphetamine (MET500) Home Rapid Test Dipstick | 1 | DME-A101H | 2026-10-12 |
| 06942598249413 | One Step® Methadone (MTD300) Home Rapid Test Dipstick | 1 | DMT-A101H | 2026-10-12 |
| 06942598249420 | One Step® Morphine (MOP/OPI2000) Home Rapid Test Dipstick | 1 | DOP-A101H | 2026-10-12 |
| 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 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06942598249383 | One Step® Buprenorphine (BUP10) Home Rapid Test Dipstick | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-10-12 |
| 06942598249390 | One Step® Benzodiazepines (BZO300) Home Rapid Test Dipstick | Hangzhou AllTest Biotech Co., Ltd. | NFV | 2026-10-12 |
| 06942598249406 | One Step® Methamphetamine (MET500) Home Rapid Test Dipstick | Hangzhou AllTest Biotech Co., Ltd. | NGG | 2026-10-12 |
| 06942598249413 | One Step® Methadone (MTD300) Home Rapid Test Dipstick | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-10-12 |
| 06942598249420 | One Step® Morphine (MOP/OPI2000) Home Rapid Test Dipstick | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-10-12 |
| 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 |
| 06936983113991 | Alltest PCP25 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGM | 2026-04-21 |
| 06936983114004 | Alltest TCA1000 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | QAW | 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 |
| 06936983114141 | Alltest PCP25 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGM | 2026-04-21 |
| 06936983114158 | Alltest TCA1000 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | QAW | 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 |