| Primary Device ID | 00657498000168 |
| NIH Device Record Key | a7c05f2b-371d-4f69-9afe-8d7e296d82d5 |
| Commercial Distribution Discontinuation | 2019-08-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | STAT-Site Hgb Controls |
| Version Model Number | 503000 |
| Catalog Number | 503000 |
| 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 | 00657498000168 [Primary] |
| JPK | Mixture, Hematology Quality Control |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-09-02 |
| Device Publish Date | 2016-09-23 |
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| 00657498002322 - HGB Controls - Low | 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. |
| 00657498002339 - HGB Controls - Low | 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. |
| 00657498002346 - HGB Controls - Normal | 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. |
| 00657498002353 - HGB Controls - Normal | 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. |
| 00657498002360 - HGB Controls - High | 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. |
| 00657498002377 - HGB Controls - High | 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. |
| 00657498001806 - Standard 1 | 2020-03-02 To provide calibration points for the Sodium, Potassium, and Chloride electrodes on the ISE module of Roche Cobas® Chemistry Sy |