AccessGUDID - DEVICE: ALBAsera Anti-K (05060242470967)

GUDID

Device Identifier (DI) Information

Brand Name: ALBAsera Anti-K
Version or Model: Z131U
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ALBA BIOSCIENCE LIMITED

Primary DI Number: 05060242470967
Issuing Agency: GS1
Commercial Distribution End Date: July 04, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 516536641 *Terms of Use

Device Description: Blood Grouping Reagent, ALBA-sera Anti-K (Polyclonal) for indirect antiglobulin test by tube technique.

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?
52593	Anti-K (KEL001) red blood cell grouping IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for K [KEL001] red blood cell antigens from the Kell system, using an agglutination method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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: 35ff3cd0-e048-44ae-a0af-e006aae55511
Public Version Date: January 25, 2023
Public Version Number: 5
DI Record Publish Date: November 14, 2014