AccessGUDID - DEVICE: DG Gel 8 Anti-E (08437014205121)

GUDID

Device Identifier (DI) Information

Brand Name: DG Gel 8 Anti-E
Version or Model: 210122
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 210122
Company Name: DIAGNOSTIC GRIFOLS SA

Primary DI Number: 08437014205121
Issuing Agency: GS1
Commercial Distribution End Date: April 15, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 463625602 *Terms of Use

Device Description: For the determination of human E antigen on the surface of red blood cells of eight human blood samples. For use with the DG Gel System. For in vitro diagnostic use.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
52562	Anti-E [RH003] 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 [RH003] 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 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 780cc278-3704-43b3-80c2-4ad333f40b5a
Public Version Date: April 16, 2025
Public Version Number: 3
DI Record Publish Date: October 29, 2015