Erytra 210401

GUDID 08437014205190

The Erytra is a fully-automated high-throughput analyzer designed to automate in vitro immunohematologial test of human blood utilizing DG Gel 8 card technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Compatability Tests, and Direct Antiglobulin Tests. As a standalone analyzer or interfaced to the customer's Laboratory Information System (LIS), the Erytra automates test processing functions and data management requirements using DG Gel 8 cards and digital image processing.

DIAGNOSTIC GRIFOLS SA

Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD
Primary Device ID08437014205190
NIH Device Record Keyf7fd9db5-0cba-425a-ba4e-bf40510aae1d
Commercial Distribution StatusIn Commercial Distribution
Brand NameErytra
Version Model Number210401
Catalog Number210401
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
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
GS108437014205190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number4
Public Version Date2022-09-16
Device Publish Date2016-09-06

On-Brand Devices [Erytra]

08437014205220The Erytra® is a fully-automated high-throughput analyzer designed to automate in vitro immunoh
08437014205190The Erytra is a fully-automated high-throughput analyzer designed to automate in vitro immunohem

Trademark Results [Erytra]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ERYTRA
ERYTRA
79049656 3543861 Live/Registered
GRIFOLS, S.A.
2007-12-05

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