| Primary Device ID | 00811727015853 |
| NIH Device Record Key | 17d32ae5-4e8d-4bb1-9f20-1ada796d2777 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pointe HbA1c for the BS480 |
| Version Model Number | 14-H7546-160 |
| Catalog Number | 14-H7546-160 |
| Company DUNS | 052845583 |
| Company Name | HORIBA INSTRUMENTS INCORPORATED |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| 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 |
| 00811727015716 - Pointe ALT for the BS480 | 2025-10-02 Pointe ALT packaged for the BS480 Analyzer. 5x60mL, 5x15mL Kit. For the quantitative determination of Alanine Aminotransferase |
| 00811727015747 - Pointe BUN on BS480 | 2025-10-02 Pointe BUN packaged for use on the BS480 analyzer. 8x60mL, 8x15mL Kit. For the quantitative determination of urea nitrogen in se |
| 00811727015761 - Pointe Creatinine Enzymatic on BS480 | 2025-10-02 Pointe Creatinine Enzymatic Reagent packaged for use on the BS480. 4x40mL, 4x14mL Kit. For the quantitative enzymatic determinat |
| 00811727015785 - Pointe Creatine Kinase for BS480 | 2025-10-02 Pointe Creatine Kinase packaged for use on the BS480. 4x40mL, 4x15mL Kit. For the quantitative determination of creatine kinase |
| 00811727015808 - Pointe Creatinine for BS480 | 2025-10-02 Pointe Creatinine reagent packaged for use on the BS480 analyzer. 6x60mL, 6x12mL Kit. For the quantitative determination of crea |
| 00811727015822 - Pointe Direct Bilirubin for BS480 | 2025-10-02 Pointe Direct Bilirubin Reagent packaged for the BS480 analyzer. 4x40mL, 4x10mL Kit. For the quantitative determination of direc |
| 00811727015853 - Pointe HbA1c for the BS480 | 2025-10-02Pointe HbA1c Reagent packaged for use on the BS480. 2x60mL, 2x20mL Kit. For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. |
| 00811727015853 - Pointe HbA1c for the BS480 | 2025-10-02 Pointe HbA1c Reagent packaged for use on the BS480. 2x60mL, 2x20mL Kit. For the quantitative determination of Hemoglobin A1c (Hb |
| 00856605006004 - MINOCAL | 2018-03-29 Whole Blood Hematology Calibrator |