DJG
- Product code
- DJG
- Device name
- Enzyme Immunoassay, Opiates
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.3650
- Medical specialty
- Clinical Toxicology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 215
510(k) clearances, last 3 years (17)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| 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 |
Official FDA classification page: DJG
Classification and pathway per current FDA publications. Data from openFDA (CC0).