CARDINAL HEALTH
- Primary DI
- 10885380173158
- Brand
- CARDINAL HEALTH
- Company
- Cardinal Health 200, LLC
- Model
- CH2450604
- Catalog number
- CH2450604
- Device description
- Beta-Hydroxybutyrate/TDM Linearity Standards
- Published
- 2019-12-11
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- OTC
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| DKB | Calibrators, drug mixture |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DKB | Calibrators, Drug Mixture | Clinical Toxicology | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10885380173158 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10885380173158 | 10885380173158 |
GMDN Terms#
| Term | Definition |
|---|---|
| Beta-hydroxybutyrate IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of beta-hydroxybutyrate (3-hydroxybutyric acid) in a clinical specimen. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 961027315
- Device count
- 1
- Premarket exempt
- true
- Kit
- true
- Lot or batch
- true
- No natural rubber latex
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10885380184895 | CARDINAL HEALTH | 82021 | 82021 | 2024-07-25 |
| 10885380184901 | CARDINAL HEALTH | 82022 | 82022 | 2024-07-25 |
| 10885380184918 | CARDINAL HEALTH | 82023 | 82023 | 2024-07-25 |
| 10885380184925 | CARDINAL HEALTH | 82024 | 82024 | 2024-07-25 |
| 50885380004818 | CONVERTORS | 9423N | 9423N | 2016-06-21 |
| 50885380009837 | CONVERTORS | 29455NA | 29455NA | 2016-06-21 |
| 50885380016972 | CONVERTORS | 29557N | 29557N | 2016-06-21 |
| 50885380020016 | CONVERTORS | 9450N | 9450N | 2016-06-21 |
| 50885380027916 | CONVERTORS | 9441N | 9441N | 2016-06-21 |
| 50885380030619 | CONVERTORS | 29444N | 29444N | 2016-06-21 |
| 50885380034068 | CONVERTORS | 29527N | 29527N | 2016-06-21 |
| 50885380034402 | CONVERTORS | 29559N | 29559N | 2016-06-21 |
| 50885380036116 | CONVERTORS | 9449N | 9449N | 2016-06-21 |
| 50885380053755 | CONVERTORS | 29421NB | 29421NB | 2016-06-21 |
| 50885380053779 | CONVERTORS | 9438NB | 9438NB | 2016-06-21 |
| 50885380053854 | CONVERTORS | 29465NB | 29465NB | 2016-06-21 |
| 50885380053878 | CONVERTORS | 29467NB | 29467NB | 2016-06-21 |
| 50885380053892 | CONVERTORS | 29522NB | 29522NB | 2016-06-21 |
| 50885380053922 | CONVERTORS | 9430NB | 9430NB | 2016-06-21 |
| 50885380053939 | CONVERTORS | 9458NB | 9458NB | 2016-06-21 |
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| 00840937114636 | Immunalysis | IMMUNALYSIS CORP | DKB | 2024-04-19 |
| 00840937114643 | Immunalysis | IMMUNALYSIS CORP | DKB | 2024-04-19 |
| 00840937114650 | Immunalysis | IMMUNALYSIS CORP | DKB | 2024-04-19 |
| 00840937114667 | Immunalysis | IMMUNALYSIS CORP | DKB | 2024-04-19 |
| 00613647025291 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | DKB | 2023-06-20 |
| 20613647025295 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | DKB | 2023-06-20 |
| 00840937112083 | Immunalysis | IMMUNALYSIS CORP | DKB | 2021-02-05 |
| 00840937112090 | Immunalysis | IMMUNALYSIS CORP | DKB | 2021-02-05 |
| 00840937112106 | Immunalysis | IMMUNALYSIS CORP | DKB | 2021-02-05 |
| 00840937112113 | Immunalysis | IMMUNALYSIS CORP | DKB | 2021-02-05 |
| 00811727016850 | Pointe Universal Negative Calibrator | HORIBA INSTRUMENTS INCORPORATED | DKB | 2020-09-25 |
| 00811727017550 | Pointe Multi-Analyte Set C Urine DAU Low Calibrator | HORIBA INSTRUMENTS INCORPORATED | DKB | 2020-09-25 |
| 00811727017567 | Pointe Multi-Analyte Set C Urine DAU Cutoff Calibrator | HORIBA INSTRUMENTS INCORPORATED | DKB | 2020-09-25 |
| 00811727017574 | Pointe Multi-Analyte Set C Urine DAU Intermediate Calibrator | HORIBA INSTRUMENTS INCORPORATED | DKB | 2020-09-25 |
| 00811727017581 | Pointe Multi-Analyte Set C Urine DAU High Calibrator | HORIBA INSTRUMENTS INCORPORATED | DKB | 2020-09-25 |
| 00811727017611 | Pointe Multi-Analyte Set D Urine DAU Negative Calibrator | HORIBA INSTRUMENTS INCORPORATED | DKB | 2020-09-25 |
| 00811727017628 | Pointe Multi-Analyte Set D Urine DAU Low Calibrator | HORIBA INSTRUMENTS INCORPORATED | DKB | 2020-09-25 |
| 00811727017635 | Pointe Multi-Analyte Set D Urine DAU Cutoff Calibrator | HORIBA INSTRUMENTS INCORPORATED | DKB | 2020-09-25 |
| 00811727017642 | Pointe Multi-Analyte Set D Urine DAU Intermediate Calibrator | HORIBA INSTRUMENTS INCORPORATED | DKB | 2020-09-25 |
| 00811727017659 | Pointe Multi-Analyte Set D Urine DAU High Calibrator | HORIBA INSTRUMENTS INCORPORATED | DKB | 2020-09-25 |
| 00811727017680 | Pointe Multi-Analyte E DAU Negative Calibrator | HORIBA INSTRUMENTS INCORPORATED | DKB | 2020-09-25 |
| 00811727017697 | Pointe Multi-Analyte E DAU Low Calibrator | HORIBA INSTRUMENTS INCORPORATED | DKB | 2020-09-25 |
| 00811727017703 | Pointe Multi-Analyte E DAU Cutoff Calibrator | HORIBA INSTRUMENTS INCORPORATED | DKB | 2020-09-25 |
| 00811727017710 | Pointe Multi-Analyte E DAU Intermediate Calibrator | HORIBA INSTRUMENTS INCORPORATED | DKB | 2020-09-25 |
| 00811727017727 | Pointe Multi-Analyte E DAU High Calibrator | HORIBA INSTRUMENTS INCORPORATED | DKB | 2020-09-25 |
| 00380740179342 | Alinity | ABBOTT LABORATORIES | DKB | 2020-05-11 |
| 00380740179359 | Alinity | ABBOTT LABORATORIES | DKB | 2020-05-11 |
| 00380740179366 | Alinity | ABBOTT LABORATORIES | DKB | 2020-05-11 |
| 00840937111895 | Immunalysis | IMMUNALYSIS CORP | DKB | 2020-03-31 |
| 00840937111918 | Immunalysis | IMMUNALYSIS CORP | DKB | 2020-03-31 |