DJG
- 产品代码
- DJG
- 器械名称
- Enzyme Immunoassay, Opiates
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 862.3650
- FDA 专业组
- Clinical Toxicology
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 215 件
该代码近三年的 510(k)（17 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K252684 | 2026-01-29 | Medtox Diagnostics, Inc. | Labcorp Fentanyl Urine Visual Test | |
| K250741 | 2026-01-23 | Randox Laboratories Limited | Evidence MultiSTAT DOA Urine MultiPlex | |
| K253082 | 2026-01-16 | Lin-Zhi International, Inc. | LZI Buprenorphine II Enzyme Immunoassay | |
| K252520 | 2025-09-11 | Immunalysis Corporation | SEFRIA Hydrocodone Oral Fluid | |
| K251972 | 2025-08-15 | Healgen Scientific,, LLC | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay | |
| K251634 | 2025-06-18 | Lin-Zhi International, Inc. | LZI Fentanyl III Enzyme Immunoassay | |
| K240124 | 2024-06-14 | Vivachek Biotech (Hangzhou) Co., Ltd. | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart | |
| K240698 | 2024-05-10 | Guangzhou Decheng Biotechnology Co., L | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Mu | |
| K231904 | 2024-03-08 | Co-Innovation Biotech Co., Ltd. | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL | |
| K232228 | 2024-02-23 | Shanghai Accurature Diagnostics Co., L | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip | |
| K232597 | 2024-01-09 | Hangzhou Laihe Biotech Co., Ltd. | LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine | |
| K232736 | 2023-12-20 | Chemtron Biotech, Inc. | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Ch | |
| K232659 | 2023-12-13 | Guangzhou Decheng Biotechnology Co., L | Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi- | FDA |
| K231752 | 2023-11-09 | Ark Diagnostics, Inc. | ARK Hydrocodone Assay | |
| K221550 | 2023-10-05 | Randox Laboratories Limited | Evidence MultiSTAT DOA Urine MultiPlex | |
| K220451 | 2023-10-05 | Randox Laboratories Limited | Evidence MultiSTAT DOA Urine MultiPlex, Evidence Mul | |
| K231007 | 2023-09-27 | Microgenics Corporation | CEDIA Heroin Metabolite (6-AM) Assay |
FDA 官方分类页： DJG
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。