WADiana Compact 213789

GUDID 08437014205183

WADiana Compact is a fully automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing the DG Gel 8 cards technology. As a standalone or interfaced to the customer's Laboratory Information System (LIS), the WADiana Compact analyzer automates test processing functions and data management requirements using DG Gel 8 cards and digital image processing.

DIAGNOSTIC GRIFOLS SA

Blood group/antibody screening analyser IVD
Primary Device ID08437014205183
NIH Device Record Keyd70b72e8-10ad-4e02-ab86-76ecd031341c
Commercial Distribution Discontinuation2025-04-15
Commercial Distribution StatusNot in Commercial Distribution
Brand NameWADiana Compact
Version Model Number213789
Catalog Number213789
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 Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108437014205183 [Primary]

FDA Product Code

KSZSystem, Test, Automated Blood Grouping And Antibody

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2025-04-16
Device Publish Date2016-09-06

Devices Manufactured by DIAGNOSTIC GRIFOLS SA

08437014205152 - DG Spin2025-04-29 DG SPIN Centrifugue is a device specifically designed to centrifuge DG Gel 8 cards.
08437014205169 - DG Therm2025-04-29 DG THERM Incubator is a device specifically designed to incubate DG Gel 8 Cards and/or test tubes at 37oC for inmmunohematology
08437014205008 - DG Gel 8 Neutral2025-04-22 The DG Gel 8 Neutral card is for the detection of antibodies to red blood cell antigens of human blood samples and for its use a
08437014205084 - DG Gel 8 Anti-K2025-04-16 The DG Gel 8 Anti-K card is for the determination of K antigen on the surface of red blood cells in eight human blood samples. F
08437014205091 - DG Gel 8 Anti-D2025-04-16 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
08437014205107 - DG Gel 8 Anti-AB2025-04-16 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
08437014205121 - DG Gel 8 Anti-E2025-04-16 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
08437014205138 - DG Gel 8 Anti-c2025-04-16 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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