| Primary Device ID | B103CSC30231 |
| NIH Device Record Key | 92721a59-66c9-4c7a-8ac4-1df6ef051767 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cardiac STATus Controls (CK-MB/MYOGLOBIN/TROPONIN I) |
| Version Model Number | CSC3023 |
| Catalog Number | CSC3023 |
| Company DUNS | 243942278 |
| Company Name | International Point of Care Incorporated |
| Device Count | 6 |
| 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 | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| B103CSC30231 - Cardiac STATus Controls (CK-MB/MYOGLOBIN/TROPONIN I) | 2022-12-15Cardiac STATus Controls (CK-MB/Myoglobin/Troponin I) are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of Cardiac STATus tests. |
| B103CSC30231 - Cardiac STATus Controls (CK-MB/MYOGLOBIN/TROPONIN I) | 2022-12-15 Cardiac STATus Controls (CK-MB/Myoglobin/Troponin I) are intended for use as assayed quality control materials in quality assura |
| B103A10CS10021 - Cardiac STATus® TnI | 2018-07-06 Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Whole Blood, Plasma, or Serum. |
| B103A10CS30021 - Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem T | 2018-07-06 Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB in Human Heparinized Whole Blood, |
| B103A20CS10021 - Cardiac STATus® TnI | 2018-07-06 Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Whole Blood, Plasma, or Serum. |
| B103A20CS30021 - Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem T | 2018-07-06 Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB in Human Heparinized Whole Blood, |
| B103A25CS10021 - Cardiac STATus® TnI | 2018-07-06 Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Whole Blood, Plasma, or Serum. |
| B103A25CS30021 - Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem T | 2018-07-06 Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB in Human Heparinized Whole Blood, |