AccessGUDID - DEVICE: ORTHOTM Sera Anti-Fyb (10758750013012)

GUDID

Device Identifier (DI) Information

Brand Name: ORTHOTM Sera Anti-Fyb
Version or Model: 6904547
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ALBA BIOSCIENCE LIMITED

Primary DI Number: 10758750013012
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 516536641 *Terms of Use

Device Description: The Anti-Fyb reagent (Anti-FY2) is for the qualitative in vitro detection of human Fyb positive red blood cells by the 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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
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?
52570	Anti-Fy^b 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 Fy^b [FY002] red blood cell antigens from the Duffy 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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0d8e844c-4222-4b6d-83a6-c8acb3b7c2ef
Public Version Date: March 25, 2025
Public Version Number: 6
DI Record Publish Date: June 21, 2017