| Primary Device ID | 04987562432615 |
| NIH Device Record Key | 67302fd6-560e-4553-8075-a65f49aacb5d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Automated Hematology Analyzer XN series XN-11 |
| Version Model Number | CS297931 |
| Company DUNS | 690664461 |
| Company Name | SYSMEX CORPORATION |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 04987562020102 - CELLPACK | 2022-12-08 CELLPACK is a reagent for measuring the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection). |
| 04987562020171 - CELLPACK | 2022-12-08 CELLPACK is a reagent for measuring the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection). |
| 04987562022090 - STROMATOLYSER-3WP | 2022-12-08 STROMATOLYSER-3WP is a lysing reagent to eliminate red blood cells and cell stroma for use in accurate determination of WBC coun |
| 04987562022335 - STROMATOLYSER-FB | 2022-12-08 STROMATOLYSER-FB is a reagent for analyzing basophil counts and WBC counts by the flow cytometry method, using a semiconductor l |
| 04987562200269 - STROMATOLYSER-IM | 2022-12-08 STROMATOLYSER-IM is lyse reagent for the IMI channel of Sysmex Automated Hematology Analyzers. |
| 04987562201389 - STROMATOLYSER-4DS | 2022-12-08 STROMATOLYSER-4DS is to be used to stain the leukocytes in diluted and lysed blood samples for determination of the 4-part diffe |
| 04987562201402 - STROMATOLYSER-4DL | 2022-12-08 The STROMATOLYSER-4DL is a reagent that lyses RBC for determination of 4-part differential count, or 5-part differential count* |
| 04987562406005 - CELLSHEATH | 2022-12-08 CELLSHEATH, in combination with the specified diluent, is a reagent for analyzing the numbers and sizes of RBC and platelets by |