STROMATOLYSER-IM

GUDID 00664369200268

Blood cell lysis reagent IVD

Primary Device ID	00664369200268
NIH Device Record Key	f7166fa6-fc20-41f8-af58-6e0c060763a5
Commercial Distribution Status	In Commercial Distribution
Brand Name	STROMATOLYSER-IM
Version Model Number	SIM-220A
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	true
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 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 30 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00664369200268 [Primary]

GGK	Products, Red-Cell Lysing Products

Steralize Prior To Use	false
Device Is Sterile	false

00664369200268	Lysing reagent for analysis of immature WBC
04987562200269	STROMATOLYSER-IM is lyse reagent for the IMI channel of Sysmex Automated Hematology Analyzers.