AccessGUDID - DEVICE: Anti-IgG (Murine Monoclonal) (Uncolored) Gamma-clone (10888234001645)

GUDID

Device Identifier (DI) Information

Brand Name: Anti-IgG (Murine Monoclonal) (Uncolored) Gamma-clone
Version or Model: 0401510
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0401510
Company Name: IMMUCOR, INC.

Primary DI Number: 10888234001645
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061446282 *Terms of Use

Device Description: This product is used in direct or indirect antiglobulin tests where the detection of IgG is required. This product contains a murine monoclonal antibodies directed at the relevant human proteins, in proportions designed to achieve optimum proportions of anti-IgG. The package configuration for this product code is ten (10) vials of reagent. The color of the liquid reagent is clear.

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:	Yes
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):

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 1 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fe2fe465-594d-4872-8a6e-598e2e49412f
Public Version Date: May 24, 2021
Public Version Number: 3
DI Record Publish Date: June 04, 2016