The Lin-Zhi International (LZI) Buprenorphine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of norbuprenorphine (a buprenorphine metabolite) in human urine at a cutoff value of 5 ng/mL and 10 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
| Ref No. | Product Name | Quantity / Kit |
|---|---|---|
| 0270 | Buprenorphine EIA Kit, small test kit | 100/37.5 mL R1/R2 Kit |
| 0271 | Buprenorphine EIA Kit, large test kit | 1000/375 mL R1/R2 Kit |
| 0001 | Negative Calibrator | 5 mL |
| 0273 | Norbuprenorphine 5 ng/mL Low Calibrator | 5 mL |
| 0275 | Norbuprenorphine 10 ng/mL Cutoff Calibrator | 5 mL |
| 0277 | Norbuprenorphine 20 ng/mL Intermediate Calibrator #1 | 5 mL |
| 0278 | Norbuprenorphine 40 ng/mL Intermediate Calibrator #2 | 5 mL |
| 0279 | Norbuprenorphine 75 ng/mL High Calibrator | 5 mL |
| 0272 | Norbuprenorphine 3 ng/mL Level 1 Control | 5 mL |
| 0274 | Norbuprenorphine 7 ng/mL Level 1/2 Control | 5 mL |
| 0276 | Norbuprenorphine 13 ng/mL Level 2 Control | 5 mL |
Product Inserts
For US Only
- LZI Buprenorphine Enzyme Immunoassay Product Insert
- LZI Norbuprenorphine Calibrators Product Insert
- LZI Norbuprenorphine Controls Product Insert
For Outside US Only
Safety Data Sheets
For US Only
For Outside US Only
Regulatory Status and Control
- United States — 510(k) cleared
- US DEA exempt chemical preparation for Calibrators and Controls
- Europe – CE Marked (IVDR)