| Primary Device ID | 00657498000564 |
| NIH Device Record Key | f75d27a5-d102-4d66-bb89-50fa660672a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Direct Bilirubin LiquiColor® |
| Version Model Number | 0235-450 |
| Catalog Number | 0235-450 |
| Company DUNS | 045361136 |
| Company Name | STANBIO LABORATORY, L.P. |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| 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 |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com |
| 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 |
|---|---|
| GS1 | 00657498000564 [Primary] |
| JFM | Enzymatic Method, Bilirubin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-23 |
| 00657498000571 | For the Quantitative Colorimetric Determination of Direct Bilirubin in Serum or Plasma. |
| 00657498000564 | For the quantitative colorimetric determination of Direct Bilirubin in Serum and Plasma. |