AccessGUDID - DEVICE: ALBAcyte IgG Sensitized Red Blood Cells (05060242471162)

GUDID

Device Identifier (DI) Information

Brand Name: ALBAcyte IgG Sensitized Red Blood Cells
Version or Model: Z441U
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ALBA BIOSCIENCE LTD

Primary DI Number: 05060242471162
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 516536641 *Terms of Use

Device Description: ALBAcyte IgG Sensitized Red Blood Cells for control of the direct and indirect antiglobulin test.

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:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Immunoglobulin G (IgG) sensitized reagent red blood cell IVD, control	A sample of specifically characterized reagent red blood cells intended to be used when testing a clinical specimen, due to their sensitization or cell coating with immunoglobulin G (IgG) antibodies, to verify the performance of an assay.

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK100005	0

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

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f84e269f-8983-4a82-9de8-79546292c5fb
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016