| Primary Device ID | 00852169008171 |
| NIH Device Record Key | d939e8a6-4611-4138-86d4-a12fdb6d7684 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ClearChem Diagnostics Inc. High Sensitivity C-Reactive Protein (hS-CRP) |
| Version Model Number | CRP1320 |
| Catalog Number | CRP1320 |
| Company DUNS | 010655581 |
| Company Name | CLEARCHEM DIAGNOSTICS INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Refrigerated |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Refrigerated |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Refrigerated |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Refrigerated |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Refrigerated |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Refrigerated |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Refrigerated |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Refrigerated |
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| 00852169008294 - ClearChem Diagnostics Inc. MicroProtein, Total | 2018-07-09 In Vitro Diagnostics testing kit R1:4X60mL, STD 1X15mL |
| 00852169008232 - ClearChem Diagnostics Inc. TIBC-Direct | 2018-06-22 In Vitro Diagnostics testing kit R1:3X30mL, R2:3X18mL |
| 00852169008270 - ClearChem Diagnostics Inc. MicroAlbumin | 2018-06-22 In Vitro Diagnostics testing kit R1:4X20mL, R2:2X10mL |
| 00852169008287 - ClearChem Diagnostics Inc. Hemoglobin A-1c | 2018-06-22 In Vitro Diagnostics testing kit Buffer:1X36mL, R1a:1X16mL, R2b:1X6.7mL, R2:1X10.1mL |
| 00852169008058 - ClearChem Diagnostics Inc. Aspartate aminotransferase (AST) | 2018-06-18 In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL |
| 00852169008164 - ClearChem Diagnostics Inc. High-Density Lipoprotein (HDL) Cholesterol | 2018-06-18 In Vitro Diagnostics testing kit R1:3X45mL, R2:3X15mL |
| 00852169008072 - ClearChem Diagnostics Inc. Carbon Dioxide (CO2) | 2018-06-11 In Vitro Diagnostics testing kit R1:6X30mL |