AccessGUDID - DEVICE: DG Gel 8 ABO/Rh+Kell (08437014205015)

GUDID

Device Identifier (DI) Information

Brand Name: DG Gel 8 ABO/Rh+Kell
Version or Model: 210383
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 210383
Company Name: DIAGNOSTIC GRIFOLS SA

Primary DI Number: 08437014205015
Issuing Agency: GS1
Commercial Distribution End Date: November 16, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 463625602 *Terms of Use

Device Description: The DG Gel 8 ABO/Rh + Kell card is for the determination of ABO forward and reverse group, and D and K antigens on the surface of red blood cells of 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?
47009	ABO/Rh(D)/Kell multiple blood grouping IVD, kit, agglutination	A collection of immunoglobulins capable of binding to specific antigenic determinants and intended to be used together in testing a clinical specimen for a combination of one or multiple ABO system, Rh(D) [RH001] and Kell [KEL001] 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 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 678b5cb7-d247-42af-b321-ae10c85fc853
Public Version Date: November 17, 2021
Public Version Number: 3
DI Record Publish Date: July 22, 2015