AccessGUDID - DEVICE: Anti-B (AB02) (23661562105216)

GUDID

Device Identifier (DI) Information

Brand Name: Anti-B (AB02)
Version or Model: 210521
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 210521
Company Name: DIAGAST

Primary DI Number: 23661562105216
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 381527001 *Terms of Use

Device Description: Blood Grouping Reagent, Anti-B (Murine Monoclonal) (9621A8) - This reagent is designed to determine the presence of ABO system blood group antigen B on the surface of human red blood cells by manual tube method.

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):

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
52538	Anti-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 group B [ABO002] red blood cell antigens, 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: 465efe6c-d69e-46af-a231-b9b05abe93a9
Public Version Date: October 21, 2020
Public Version Number: 2
DI Record Publish Date: May 01, 2018