FDA.reportPublic FDA data

Erytra

Primary DI
08437014205190
Brand
Erytra
Company
DIAGNOSTIC GRIFOLS SA
Model
210401
Catalog number
210401
Device description
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.
Published
2016-09-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSZSystem, Test, Automated Blood Grouping And Antibody

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSZSystem, Test, Automated Blood Grouping And AntibodyHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1300670

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1300670

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08437014205190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437014205190084370142051908437014205190

GMDN Terms#

Term, Definition table
TermDefinition
Immunohaematology/blood bank analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used to perform blood grouping, red cell phenotyping, antibody screening/identification/titration, direct antiglobulin tests and/or crossmatching of clinical specimens (from donor and patient). It utilizes one or more immunological methods which may include microplate agglutination, column agglutination technology or nephelometry, together with an enzymic, photometric or radiometric detection system, and sample processing, data processing and/or data display software.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800)452-6877service.americas@grifols.com

Regulatory Flags#

DUNS number
463625602
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08436583731802DG Gel Anti-K2102252102252026-05-26
08436583730478DG Gel AB (x4)2103462103462026-05-25
08436583731888Grifols Wash Solution A2136822136822026-03-13
08436583731895Grifols Wash Solution B2136832136832026-03-13
08437014205008DG Gel 8 Neutral2103932103932020-11-16
08437014205244Grifols Diluent2136772136772016-09-06
08436583731024DG Gel 8 Anti-D2102022102022022-10-10
08436583731031DG Gel 8 Anti-AB2102002102002022-10-10
08436583731055DG Gel 8 Anti-C2102012102012022-10-10
08436583731062DG Gel 8 Anti-E2102242102242022-10-10
08436583731079DG Gel 8 Anti-c2102262102262022-10-10
08436583731086DG Gel 8 Anti-e2102272102272022-10-10
08436583731093DG Gel 8 Rh Pheno2102282102282022-08-12
08437014205909DG Gel 8 Direct Coombs2101292022-07-08
08437014205060DG Gel 8 Anti-IgG (Rabbit)2103942103942015-07-22
08437014205947DG Gel 8 AB (x4)2103862103862021-03-15
08437014205930DG Gel 8 A/B/D2103842103842021-01-21
08437014205916DG Gel 8 ABO/Rh (2D)2101282101282020-05-06
08437014205220Erytra2104002104002019-05-20
08437014205152DG Spin2103632103632016-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05713494002829ELDON SCHOOL KIT SKA 2511-30Eldon Biologicals A/SKSZ2026-05-19
05713494002836ELDON SCHOOL KIT SK 2511-30Eldon Biologicals A/SKSZ2026-05-19
05713494002843ELDON SCHOOL KIT SKA 2521-25Eldon Biologicals A/SKSZ2026-05-19
05713494002683ELDON MILITARY KIT MKA 2521-25Eldon Biologicals A/SKSZ2024-07-05
05713494002690ONE MAN KIT OKA 2511-1Eldon Biologicals A/SKSZ2024-07-05
05713494002638ELDON HOME KIT HKA 2511-1Eldon Biologicals A/SKSZ2023-03-08
05713494002409ELDON HOME KIT HKA 2511-1Eldon Biologicals A/SKSZ2022-11-28
05713494002546ELDON SCHOOL KIT SKA 2521-25Eldon Biologicals A/SKSZ2022-10-04
10888234001553Capture-R SelectIMMUCOR, INC.KSZ2022-09-03
03610522055685IH-Card ABO NeutralBio-Rad Medical Diagnostics GmbHKSZ2022-03-09
05713494002287ELDON SCHOOL KIT SKA 2511-30Eldon Biologicals A/SKSZ2021-11-11
05713494002270ELDON HOME KIT HKA 2511-1Eldon Biologicals A/SKSZ2021-09-16
05713494002225ELDON SCHOOL KIT SKA 2521-25Eldon Biologicals A/SKSZ2021-05-31
05713494001990ELDON HOME KIT HKA 2511-1Eldon Biologicals A/SKSZ2021-04-27
10758750032846ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.KSZ2021-04-07
03610522123919IH-Com V5.2Bio-Rad Medical Diagnostics GmbHKSZ2021-02-18
05713494001976ELDONBOX 2521-100 100 ELDONCARD 2521Eldon Biologicals A/SKSZ2021-02-04
05713494000313ELDONBOX 2521-100 100 ELDONCARD 2521Eldon Biologicals A/SKSZ2021-02-04
05713494001808ELDON SCHOOL KIT SK 2511-30Eldon Biologicals A/SKSZ2020-12-12
05713494001952ELDON HOME KIT HKA 2511-2Eldon Biologicals A/SKSZ2020-12-12
05713494001969ELDON HOME KIT HKA 2511-5Eldon Biologicals A/SKSZ2020-12-12
05713494000306ELDON HOME KIT HKA 2511-5Eldon Biologicals A/SKSZ2020-12-12
05060496770066Ortho ConnectBIOMEDICAL DATA SOLUTIONS LIMITEDKSZ2020-11-18
08437014205008DG Gel 8 NeutralDIAGNOSTIC GRIFOLS SAKSZ2020-11-16
05713494001785ELDONBOX 2511-100 100 ELDONCARD 2511Eldon Biologicals A/SKSZ2020-11-04
05713494001792ELDON SCHOOL KIT SKA 2511-30Eldon Biologicals A/SKSZ2020-11-04
05713494001761ELDON HOME KIT HKA 2511-1Eldon Biologicals A/SKSZ2020-11-04
05713494001778ELDON HOME KIT HKA 2511-1Eldon Biologicals A/SKSZ2020-11-04
05713494001754ELDON HOME KIT HKA 2511-1Eldon Biologicals A/SKSZ2020-08-31
14987666543344PK7400Beckman Coulter, Inc.KSZ2020-07-06