AccessGUDID - DEVICE: Anti-e (Monoclonal Blend) Gamma-clone (10888234001379)

GUDID

Device Identifier (DI) Information

Brand Name: Anti-e (Monoclonal Blend) Gamma-clone
Version or Model: 0066424
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0066424
Company Name: IMMUCOR, INC.

Primary DI Number: 10888234001379
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061446282 *Terms of Use

Device Description: This reagent is used for the detection of the e antigen (Rhesus blood group system) on red blood cells by tube test. This product configuration is a single vial.

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?
52563	Anti-E [RH005] 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 E [RH005] red blood cell antigens from the rhesus 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 1 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8925db07-47f6-4fa4-b5fc-9cddbe4154dd
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 04, 2016