| Primary Device ID | 00811727010414 |
| NIH Device Record Key | 1eaea16b-c990-4c76-b367-cdb4765eb974 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | POINTE SCIENTIFIC Bilirubin, Direct |
| Version Model Number | B7538-500 |
| Catalog Number | B7538-500 |
| Company DUNS | 045623154 |
| Company Name | POINTE SCIENTIFIC, 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 |
| Phone | 800-445-9853 |
| techservice@medtest.com | |
| Phone | 800-445-9853 |
| techservice@medtest.com |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811727010414 [Primary] |
| CIG | Diazo Colorimetry, Bilirubin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-31 |
| 00811727010421 | For the quantitative determination of direct bilirubin in serum. |
| 00811727010414 | For the quantitative determination of direct bilirubin in serum. |
| 00811727010407 | For the quantitative determination of direct bilirubin in serum. |