STROMATOLYSER-4DS

GUDID 80664369201384

White blood cell count IVD, reagent

Primary Device ID	80664369201384
NIH Device Record Key	8557963b-392f-45ee-a4d9-96effe23b23f
Commercial Distribution Status	In Commercial Distribution
Brand Name	STROMATOLYSER-4DS
Version Model Number	FFS-800A
Company DUNS	690664461
Company Name	SYSMEX CORPORATION
Device Count	3
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	false
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

Special Storage Condition, Specify	Between 0 and 0 *DO NOT FREEZE
Storage Environment Temperature	Between 2 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *DO NOT FREEZE
Storage Environment Temperature	Between 2 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *DO NOT FREEZE
Storage Environment Temperature	Between 2 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *DO NOT FREEZE
Storage Environment Temperature	Between 2 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *DO NOT FREEZE
Storage Environment Temperature	Between 2 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *DO NOT FREEZE
Storage Environment Temperature	Between 2 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *DO NOT FREEZE
Storage Environment Temperature	Between 2 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *DO NOT FREEZE
Storage Environment Temperature	Between 2 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *DO NOT FREEZE
Storage Environment Temperature	Between 2 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *DO NOT FREEZE
Storage Environment Temperature	Between 2 Degrees Celsius and 35 Degrees Celsius

Device Issuing Agency	Device ID
GS1	10664369201385 [Primary]
GS1	80664369201384 [Unit of Use]

KQC	Stains, Hematology

Steralize Prior To Use	false
Device Is Sterile	false

80664369201384	Stain reagent for hematology analyzers
04987562201389	STROMATOLYSER-4DS is to be used to stain the leukocytes in diluted and lysed blood samples for d