STROMATOLYSER-4DL

GUDID 00664369201418

Blood cell lysis reagent IVD

Primary Device ID	00664369201418
NIH Device Record Key	a0d269d8-8824-4746-ae3b-0db8523f63a9
Commercial Distribution Status	In Commercial Distribution
Brand Name	STROMATOLYSER-4DL
Version Model Number	FFD-200A
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 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
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	00664369201418 [Primary]

GGK	Products, Red-Cell Lysing Products

Steralize Prior To Use	false
Device Is Sterile	false

00664369201418	Lysing reagent for hematology analyzers
04987562407767	The STROMATOLYSER-4DL is a reagent that lyses RBC for determination of 4-part differential count
04987562201402	The STROMATOLYSER-4DL is a reagent that lyses RBC for determination of 4-part differential count