| Primary Device ID | 00815762021978 |
| NIH Device Record Key | 22c5ca3f-6a22-4864-b003-2193de22f151 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | R & D Systems, Inc. CBC-PIX Hematology Control |
| Version Model Number | P002 |
| Company DUNS | 087248183 |
| Company Name | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| OTC Over-The-Counter | false |
| 00815762026362 - Research and Diagnostic Systems | 2025-06-16 CBC-XN 12 x 3 mL (4 each Levels 1, 2 and 3) |
| 00815762026508 - Research and Diagnostic Systems | 2025-06-12 CBC-LINE Kit: 6 x 3mL (6 vials each of the various levels) RBC Levels 1-6, WBC Levels 1,3,6,8,10,11 PLT Levels 1,4,7,10,12,13 Lo |
| 00815762020520 - R&D CBC-XR Hematology Control | 2024-04-10 CBC-XR 10 x 4.5 mL (5 each Levels 2 and 3) |
| 00815762020537 - R&D CBC-XR Hematology Control | 2024-04-10 CBC-XR 12 x 4.5 mL (4 each Levels 1, 2 and 3) |
| 00815762020605 - R&D CBC-XR Hematology Control | 2024-04-10 CBC-XR 6 x 4.5 mL (2 each Levels 1, 2 and 3) |
| 00815762026331 - R&D CBC-DH Hematology Control | 2023-07-10 6 x 3 mL; 2 each level low, normal & high |
| 00815762026348 - R&D CBC-DH Hematology Control | 2023-07-10 12 x 3 mL; 4 each level low, normal, high |
| 00815762021978 - R & D Systems, Inc. CBC-PIX Hematology Control | 2019-01-07CBC-PIX Hematology Control |
| 00815762021978 - R & D Systems, Inc. CBC-PIX Hematology Control | 2019-01-07 CBC-PIX Hematology Control |