L-Cup
- Primary DI
- 10722066006747
- Brand
- L-Cup
- Company
- BTNX Inc
- Model
- D12.5.1-1VL
- Device description
- L-Cup Home Rapid Test (Urine). For the rapid detection of the following drugs in human urine: AMP500 BAR300 BUP10 BZO300 COC150 MDMA500 MTD300 MET500 MOP2000 OXY100 THC50 PCP25
- Published
- 2023-04-03
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- true
- Sterile
- false
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| NFT | Test, Amphetamine, Over The Counter |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| NFT | Test, Amphetamine, 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 |
|---|---|---|---|---|
| 10722066006747 | Package | GS1 | 25 | In Commercial Distribution |
| 20722066006744 | Package | GS1 | 100 | In Commercial Distribution |
| 00722066006740 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10722066006747 | 10722066006747 | ||
| 20722066006744 | 20722066006744 | ||
| 00722066006740 | 00722066006740 | 722066006740 | 0722066006740 |
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. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 251005005
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- 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 |
|---|---|---|---|---|
| 10722066015053 | Rapid Response | D12.49-1VAF | 2026-05-15 | |
| 10722066015084 | Rapid Response | D13.5-1VF | 2026-05-15 | |
| 10722066011260 | Rapid Response | D13.5-1VF | 2026-01-19 | |
| 10722066011277 | Rapid Response | D12.49-1VAF | 2026-01-19 | |
| 20722066011267 | Rapid Response | D13.5-1VF | 2026-01-19 | |
| 20722066011274 | Rapid Response | D12.49-1VAF | 2026-01-19 | |
| 10722066011338 | Rapid Response | FOB-9C36 | FOB-9C36 | 2026-01-02 |
| 20722066011335 | Rapid Response | FOB-9C36 | FOB-9C36 | 2026-01-02 |
| 00722066000205 | Rapid Response | HCG-3C50 | HCG-3C50 | 2016-10-25 |
| 00722066000267 | Rapid Response | HCG-3C25 | HCG-3C25 | 2016-10-25 |
| 00722066004548 | Rapid Response | D12.5-1V | 2019-01-21 | |
| 10722066009083 | Rapid Response | D12.49-1VA | 2025-10-03 | |
| 10722066010973 | Rapid Response | D13.5-1V | 2025-07-08 | |
| 00722066010976 | Rapid Response | D13.5-1V | 2025-07-08 | |
| 10722066009601 | Rapid Response | COF-19CGHU2 | 2025-05-29 | |
| 10722066009618 | Rapid Response | COF-19CGHU4 | 2025-05-29 | |
| 10722066010751 | Rapid Response | STR-15SGPU-25 | 2025-05-29 | |
| 10722066009595 | Rapid Response | COF-19CGHU1 | 2025-05-29 | |
| 00722066009604 | Rapid Response | COF-19CGHU2 | 2025-05-29 | |
| 00722066009611 | Rapid Response | COF-19CGHU4 | 2025-05-29 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 16936983131633 | Multi-Drug Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-16 |
| 16936983131640 | Multi-Drug Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-16 |
| 16936983131657 | Multi-Drug Test Cup (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-16 |
| 16936983131664 | Multi-Drug Test Cup (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-16 |
| 16936983131671 | Multi-Drug Test Cup (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-16 |
| 16936983131695 | Multi-Drug Test Cup (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-16 |
| 16936983138632 | Multi-Drug 12 Drugs Rapid Test Cup | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-16 |
| 16936983141120 | Discover Multi-Drug 12 Drugs Rapid Test Cup | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-16 |
| 16936983141137 | Discover Multi-Drug 12 Drugs Rapid Test Cup | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-16 |
| 16936983144688 | Discover Multi-Drug 10 Drugs Rapid Test Cup (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-16 |
| 16936983144770 | Discover Multi-Drug 9 Drugs Rapid Test Cup (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-16 |
| 16936983148846 | Discover Multi-Drug 12 Drugs Rapid Test Cup (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-16 |
| 16936983153819 | Discover Multi-Drug 13 Drugs Rapid Test Cup (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-15 |
| 16936983165379 | Discover Multi-Drug 5 Drugs Rapid Test Cup(Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-15 |
| 16936983169599 | Alltest Multi-Drug Rapid Urine Test Panel | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-15 |
| 16936983169605 | Alltest Multi-Drug Rapid Urine Test Panel | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-15 |
| 16936983169865 | Discover Multi-Drug 6 Drugs Rapid Test Cup (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-15 |
| 16936983169872 | Discover Multi-Drug 8 Drugs Rapid Test Cup (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-15 |
| 16936983170007 | Alltest Multi-Drug 12 Drugs Urine Test Panel | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-15 |
| 16936983170014 | Alltest Multi-Drug 13 Drugs Urine Test Panel | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-15 |
| 16936983170021 | Alltest Multi-Drug 14 Drugs Urine Test Panel | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-15 |
| 16936983170038 | Alltest Multi-Drug 14 Drugs Urine Test Panel | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-15 |
| 16936983171998 | Alltest Multi-Drug 13 Drugs Rapid Urine Test Panel | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-15 |
| 16936983172025 | Alltest Multi-Drug 13 Drugs Rapid Urine Test Panel | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-15 |
| 16936983172414 | Alltest Multi-Drug 13 Drugs Rapid Urine Test Panel | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-14 |
| 16936983172421 | Alltest Multi-Drug 12 Drugs Rapid Urine Test Panel | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-14 |
| 16936983179642 | Alltest Multi-Drug 13 Drugs Rapid Urine Test Panel | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-14 |
| 16936983179963 | Multi-Drug 12 Drugs Rapid Test Cup (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-14 |
| 16936983180600 | Alltest Multi-Drug 13 Drugs Test Cup | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-14 |
| 16936983180617 | Alltest Multi-Drug 14 Drugs Test Cup | Hangzhou AllTest Biotech Co., Ltd. | NFT | 2026-04-14 |