| Primary Device ID | 00811727015785 |
| NIH Device Record Key | 370dd4af-7eaa-4feb-bdd2-b9991e572066 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pointe Creatine Kinase for BS480 |
| Version Model Number | 14-C7522-220 |
| Catalog Number | 14-C7522-220 |
| 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 |
| Phone | 800-445-9853 |
| techservice@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811727015785 [Primary] |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-10-02 |
| Device Publish Date | 2020-05-28 |
| 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 | 2025-10-02Pointe Creatine Kinase packaged for use on the BS480. 4x40mL, 4x15mL Kit. For the quantitative determination of creatine kinase activity in serum. For in vitro diagnostic use only. |
| 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 | 2025-10-02 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 |