Primary Device ID | 04987562424214 |
NIH Device Record Key | 72cf0cd3-243e-4710-bd2a-c63973f17d0e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Automated Hematology Analyzer XN series XN-10 |
Version Model Number | AP795756 |
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 |