| 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 |
| Phone | 612-656-4501 |
| alicia.felthauser@bio-techne.com | |
| Phone | 612-656-4501 |
| alicia.felthauser@bio-techne.com | |
| Phone | 612-656-4501 |
| alicia.felthauser@bio-techne.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815762021978 [Primary] |
| JCN | Control, Cell Counter, Normal And Abnormal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-07 |
| Device Publish Date | 2018-12-05 |
| 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 |
| 20815762020340 - Research and Diagnostic Systems | 2018-07-06 CBC-7: 6 x 2mL Normal Pack |
| 20815762020937 - Research and Diagnostic Systems | 2018-07-06 CD-Cal (Calibrator): 5 x 3mL |