AccessGUDID - DEVICE: ALBAcheck BGS Reagent Control for Anti-D (05060242471513)

GUDID

Device Identifier (DI) Information

Brand Name: ALBAcheck BGS Reagent Control for Anti-D
Version or Model: Z271U
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ALBA BIOSCIENCE LIMITED

Primary DI Number: 05060242471513
Issuing Agency: GS1
Commercial Distribution End Date: June 18, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 516536641 *Terms of Use

Device Description: ALBAcheck BGS Reagent Control for Anti-D.

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?
52705	Antisera matrix (non-reactive) IVD, control	A material consisting of antisera matrix but containing no active immunoglobulins that is intended be used as a negative control to verify the performance of an assay when testing a clinical specimen for red blood cell antigens.	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: f4f42f2a-bc15-441a-a385-440b7693f739
Public Version Date: March 31, 2022
Public Version Number: 9
DI Record Publish Date: November 28, 2014