AccessGUDID - DEVICE: Anti-Human Globulin Anti-IgG

GUDID

Device Identifier (DI) Information

Brand Name: Anti-Human Globulin Anti-IgG - Green
Version or Model: 210547
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 210547
Company Name: DIAGAST

Primary DI Number: 23661562105476
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 381527001 *Terms of Use

Device Description: Anti-Human Globulin Anti-IgG (Murine Monoclonal) (18833+18896) is intended for use in the direct antiglobulin test to detect in vivo coating on human red blood cells with IgG and for the indirect antiglobulin test for antibody screening and identification, and crossmatch and for erythrocyte phenotyping with blood phenotyping reagents requiring an indirect antiglobulin test 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?
46948	Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody	One or multiple immunoglobulins capable of binding to human antibodies from immunoglobulin class G (IgG) that are fixed to red blood cell antigens. This immunoglobulin, known as monospecific immunoglobulin G antihuman globulin (IgG AHG) is intended to be used in immunohaematological testing of a clinical specimen to detect red blood cell sensitization by human IgG, using an agglutination or solid-phase red blood cell adherence 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: acc1817d-be66-4089-b557-10a7009bce0d
Public Version Date: May 24, 2021
Public Version Number: 3
DI Record Publish Date: May 01, 2018