| Primary Device ID | 00657498001967 |
| NIH Device Record Key | 5d7f54fa-9c3f-4809-a3dd-58406922de6f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Procalcitonin (PCT) Calibrators |
| Version Model Number | 2310-601 |
| Catalog Number | 2310-601 |
| 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 | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| 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 | 00657498001967 [Primary] |
| PTF | Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission |
| 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 | 2017-06-26 |
| 00657498002094 - Uri-Trak 120 M Urine Analyzer | 2023-06-16 The Uri-Trak® 120 M Urine Analyzer is intended for use in conjunction with the Uri-Chek® 10SG Urinalysis Reagent Strips for th |
| 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 |