DG Gel 8 ABO/Rh+Kell 210383

GUDID 08437014205015

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.

DIAGNOSTIC GRIFOLS SA

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Primary Device ID08437014205015
NIH Device Record Key678b5cb7-d247-42af-b321-ae10c85fc853
Commercial Distribution Discontinuation2021-11-16
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDG Gel 8 ABO/Rh+Kell
Version Model Number210383
Catalog Number210383
Company DUNS463625602
Company NameDIAGNOSTIC GRIFOLS SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800)452-6877
Emailservice.americas@grifols.com
Phone(800)452-6877
Emailservice.americas@grifols.com
Phone(800)452-6877
Emailservice.americas@grifols.com
Phone(800)452-6877
Emailservice.americas@grifols.com
Phone(800)452-6877
Emailservice.americas@grifols.com
Phone(800)452-6877
Emailservice.americas@grifols.com
Phone(800)452-6877
Emailservice.americas@grifols.com
Phone(800)452-6877
Emailservice.americas@grifols.com
Phone(800)452-6877
Emailservice.americas@grifols.com
Phone(800)452-6877
Emailservice.americas@grifols.com
Phone(800)452-6877
Emailservice.americas@grifols.com
Phone(800)452-6877
Emailservice.americas@grifols.com
Phone(800)452-6877
Emailservice.americas@grifols.com
Phone(800)452-6877
Emailservice.americas@grifols.com
Phone(800)452-6877
Emailservice.americas@grifols.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108437014205015 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-11-17
Device Publish Date2015-07-22

On-Brand Devices [DG Gel 8 ABO/Rh+Kell]

08437014205923The DG Gel 8 ABO/Rh + Kell card is for the determination of ABO forward and reverse group, and D
08437014205015The DG Gel 8 ABO/Rh + Kell card is for the determination of ABO forward and reverse group, and D

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