| Primary Device ID | 06970291985222 |
| NIH Device Record Key | a793dfc9-7a4d-4ca4-8491-8a59875dbc57 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Microalbuminuria Kit (Immunoturbidimetric Method) |
| Version Model Number | None |
| Company DUNS | 545261989 |
| Company Name | Medicalsystem Biotechnology Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06970291985222 [Primary] |
| DCF | Albumin, Antigen, Antiserum, Control |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-15 |
| Device Publish Date | 2019-03-07 |
| 06970291985154 - Aspartate Aminotransferase Kit (Colorimetric Metho | 2019-03-15 |
| 06970291985161 - Haptoglobin Kit (Immunoturbidimetric Method) | 2019-03-15 |
| 06970291985178 - Lactate Dehydrogenase Kit (Kinetic Method) | 2019-03-15 |
| 06970291985185 - Lactate Dehydrogenase Isozyme 1 Kit (Kinetic Metho | 2019-03-15 |
| 06970291985192 - Total Protein Kit (Biuret Method) | 2019-03-15 |
| 06970291985208 - Total Protein Kit (Biuret Method) (2-Part Reagents | 2019-03-15 |
| 06970291985215 - β2-Microglobin Kit (Latex-Enhanced Immunoturbidim | 2019-03-15 |
| 06970291985222 - Microalbuminuria Kit (Immunoturbidimetric Method) | 2019-03-15 |
| 06970291985222 - Microalbuminuria Kit (Immunoturbidimetric Method) | 2019-03-15 |