AccessGUDID - DEVICE: STROMATOLYSER-3WP (04987562022090)

GUDID

Device Identifier (DI) Information

Brand Name: STROMATOLYSER-3WP
Version or Model: 85400121
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SYSMEX CORPORATION

Primary DI Number: 04987562022090
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690664461 *Terms of Use

Device Description: STROMATOLYSER-3WP is a lysing reagent to eliminate red blood cells and cell stroma for use in accurate determination of WBC counts and tri-modal WBC distribution analysis. STROMATOLYSER-3WP is a clear reagent manufactured for use with selected Sysmex Automated Hematology Analyzers.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61165	Blood cell lysis reagent IVD	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGK	Products, Red-Cell Lysing Products

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 5 Liter

Device Record Status

Public Device Record Key: e67f0dba-16eb-4e6a-8e32-a56d820d28cb
Public Version Date: December 08, 2022
Public Version Number: 1
DI Record Publish Date: November 30, 2022