STROMATOLYSER-4DS

GUDID 04987562201389

Blood cell lysis reagent IVD

Primary Device ID	04987562201389
NIH Device Record Key	90f8db08-6956-4955-817f-146e55986116
Commercial Distribution Status	In Commercial Distribution
Brand Name	STROMATOLYSER-4DS
Version Model Number	98417216
Company DUNS	690664461
Company Name	SYSMEX CORPORATION
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	false
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

Storage Environment Temperature	Between 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 35 Degrees Celsius

Device Issuing Agency	Device ID
GS1	04987562201389 [Primary]

GGK	Products, Red-Cell Lysing Products

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