AccessGUDID - DEVICE: Alsevers Solution (07611969951369)

GUDID

Device Identifier (DI) Information

Brand Name: Alsevers Solution
Version or Model: 806510100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 806510100
Company Name: Bio-Rad Medical Diagnostics GmbH

Primary DI Number: 07611969951369
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312576506 *Terms of Use

Device Description: Suspension medium and stabilizer for red blood cells for TANGO instruments and other immunohaematology methods

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:	Yes
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?
52735	Cell preservation/storage/dilution solution IVD	A solution intended to be used for the preservation, storage, washing, dilution and/or resuspension of cells (e.g., red and/or white blood cells, epithelial, bacterial, fungal, etc.) in a clinical specimen or a cell isolate, to maintain cell stability and/or facilitate further in vitro diagnostic testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSZ	System, Test, Automated Blood Grouping And Antibody

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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fa261f40-2095-4d1a-b856-80d4138c3143
Public Version Date: October 10, 2022
Public Version Number: 5
DI Record Publish Date: July 01, 2015