Model: CY754019
Catalog: ZA900014
DI: 00664369000899
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
Lysing reagent for hematology analyzers
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3565a95d-f17b-4c06-af90-e584b4abea12
Distribution Status:
In Commercial Distribution
DUNS Number:
690664461
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00664369000899
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61165
Name: Blood cell lysis reagent IVD
Definition:
A substance or reactant intended to be used alone or in combination with other IVDs to disrupt the cell membrane of blood cells [red blood cells (RBCs), white blood cells (WBCs) and/or platelets] to release cytoplasmic contents in preparation for further analysis.
FDA Product Codes
GGK
Products, Red-Cell Lysing Products
Device Sizes
Device Size - Size - @attributes - Unit:
Liter
Device Size - Size - @attributes - Value:
5
Device Size - Size Type:
Total Volume
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
2
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
35
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Type:
Special Storage Condition, Specify
Item #2 - Storage Handling Special Condition Text:
Do not freeze. Avoid direct sunlight and dust.