Standard 1 A469-97
GUDID 00657498001806
To provide calibration points for the Sodium, Potassium, and Chloride electrodes on the ISE module of Roche Cobas® Chemistry Systems.
STANBIO LABORATORY, L.P.
Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator| Primary Device ID | 00657498001806 |
| NIH Device Record Key | 1902d2df-0880-4972-8dad-03ca2056abe6 |
| Commercial Distribution Discontinuation | 2020-02-29 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Standard 1 |
| Version Model Number | A469-97 |
| Catalog Number | A469-97 |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| 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 | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00657498001806 [Primary] |
FDA Product Code
| JIX | Calibrator, Multi-Analyte Mixture |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-03-02 |
| Device Publish Date | 2016-09-24 |
Devices Manufactured by STANBIO LABORATORY, L.P.
| 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 | 2020-03-02To provide calibration points for the Sodium, Potassium, and Chloride electrodes on the ISE module of Roche Cobas® Chemistry Systems. |
| 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 |
Trademark Results [Standard 1]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STANDARD 1 78458385 not registered Dead/Abandoned |
Shoji, Yoonah 2004-07-28 |
 STANDARD 1 77559045 not registered Dead/Abandoned |
Shoji, Yoonah 2008-08-29 |
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