Automated Hematology Analyzer XN-L series XN-530

GUDID 04987562434565

Haematological cell analyser IVD, automated

Primary Device ID	04987562434565
NIH Device Record Key	3824fba6-369c-4432-b46c-03ab75905fa4
Commercial Distribution Status	In Commercial Distribution
Brand Name	Automated Hematology Analyzer XN-L series XN-530
Version Model Number	BQ391107
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

Device Issuing Agency	Device ID
GS1	04987562434565 [Primary]

GKZ	Counter, differential cell

Steralize Prior To Use	false
Device Is Sterile	false

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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).
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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*