AccessGUDID - DEVICE: ALBAsure QC Kit (05060242471353)

GUDID

Device Identifier (DI) Information

Brand Name: ALBAsure QC Kit
Version or Model: Z481U
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ALBA BIOSCIENCE LIMITED

Primary DI Number: 05060242471353
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 516536641 *Terms of Use

Device Description: Qualitative controls for the quality control of routine blood bank reagents. The ALBAsure® QC Kit is intended for daily use to evaluate ABO, RhD and antibody screening reagents by manual blood grouping 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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
55868	Red blood cell count IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of red blood cell (erythrocyte) count and/or the calculation of intermediate red cell parameters in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSF	Kit, Quality Control For Blood Banking Reagents

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b939f7d0-5c9c-40d5-a12b-661ace34d9c7
Public Version Date: March 31, 2022
Public Version Number: 4
DI Record Publish Date: July 15, 2015