| Primary Device ID | B07602700 |
| NIH Device Record Key | e7d724c5-b633-4282-8a26-805444b03fd8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Buprenorphine Enzyme Immunoassay |
| Version Model Number | 0270 |
| Catalog Number | 0270 |
| Company DUNS | 840839190 |
| Company Name | LIN-ZHI INTERNATIONAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B07602700 [Primary] |
| DJG | Enzyme Immunoassay, Opiates |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2018-10-15 |
| Device Publish Date | 2016-07-05 |
| 00869335000204 | 2 x 100 Test Kit. Antibody/Substrate Reagent (R1): 2 x 20 mL. Enzyme Conjugate Reagent (R2): 2 x |
| 00850624008018 | 200 tests. Antibody/Substrate Reagent (R1): 1 x 24.0 mL. Enzyme Conjugate Reagent (R2): 1 x 10. |
| B07602710 | Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL. |
| B07602700 | Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL. |
| 00850624008513 | 240 tests. c pack green, PCh Antibody/Substrate Reagent (R1): 1 x 24.0 mL Enzyme Conjugate Reage |