DG Gel 8 Anti-IgG (Rabbit) 210394

GUDID 08437014205060

The DG Gel 8 Anti-IgG (Rabbit) card is for the Direct and Indirect Antiglobulin Test of human blood samples. This test does not contain antibodies to complement components. For use with the DG Gel System. For in vitro diagnostic use.

DIAGNOSTIC GRIFOLS SA

Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
Primary Device ID08437014205060
NIH Device Record Keyd25e31d7-9bdf-496e-9b4a-c8df2a715919
Commercial Distribution StatusIn Commercial Distribution
Brand NameDG Gel 8 Anti-IgG (Rabbit)
Version Model Number210394
Catalog Number210394
Company DUNS463625602
Company NameDIAGNOSTIC GRIFOLS SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS108437014205060 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-05-24
Device Publish Date2015-07-22

Devices Manufactured by DIAGNOSTIC GRIFOLS SA

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08436583731024 - DG Gel 8 Anti-D2022-10-18 The DG Gel 8 Anti-D card is for the determination of D antigen on the surface of red blood cells of eight human blood samples. F
08436583731031 - DG Gel 8 Anti-AB2022-10-18 The DG Gel 8 Anti-AB card is for the determination of human A and B antigens on the surface of red blood cells of eight human bl
08436583731055 - DG Gel 8 Anti-C2022-10-18 For the determination of human C antigen on the surface of red blood cells of eight human blood samples. For use with the DG Gel
08436583731062 - DG Gel 8 Anti-E2022-10-18 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
08436583731079 - DG Gel 8 Anti-c2022-10-18 For the determination of human c antigen on the surface of red blood cells of eight human blood samples. For use with the DG Gel

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