| Primary Device ID | 00657498000243 |
| NIH Device Record Key | 0cb40e9c-3b5f-4ad9-a323-9b718bb96833 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bi-Level Hgb Controls |
| Version Model Number | 3065-601 |
| Catalog Number | 3065-601 |
| Company DUNS | 045361136 |
| Company Name | STANBIO LABORATORY, L.P. |
| 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 | 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 | 00657498000243 [Primary] |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-04-18 |
| Device Publish Date | 2016-09-23 |
| 00657498001431 | A bi-level reference control set intended for use on HemoPoint® H2 Hemoglobin testing system. |
| 00657498000243 | A bi-level reference control set intended for use on HemoPoint® H2 Hemoglobin testing system. |