AccessGUDID - DEVICE: ALBAcyte C3 Coated Red Blood Cells (05060242471612)

GUDID

Device Identifier (DI) Information

Brand Name: ALBAcyte C3 Coated Red Blood Cells
Version or Model: Z482U
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ALBA BIOSCIENCE LIMITED

Primary DI Number: 05060242471612
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 516536641 *Terms of Use

Device Description: For control of the indirect and direct antiglobulin test. ALBAcyte® C3 Coated Red Blood Cells is used as a control to confirm the presence or absence of Anti-C3 reactivity of Anti-Human Globulin Reagent and as indicator cells in AHG testing.

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
52711	Complement coated 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 complement associated proteins, to verify the performance of an assay.	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: 11afd71c-3bf0-4510-94df-45169c2cc00f
Public Version Date: March 31, 2022
Public Version Number: 4
DI Record Publish Date: August 21, 2015