| Primary Device ID | B0760021B0 |
| NIH Device Record Key | 774dbe92-2860-4d79-99b3-f9d761ff373d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Opiate Enzyme Immunoassay |
| Version Model Number | 0021b |
| Catalog Number | 0021b |
| 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 | B0760021B0 [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 | 4 |
| Public Version Date | 2018-08-24 |
| Device Publish Date | 2016-07-05 |
| B0760021B0 | Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL. |
| B0760020B0 | Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL. |