FDA.reportPublic FDA data

DG Gel 8 Neutral

Primary DI
08437014205008
Brand
DG Gel 8 Neutral
Company
DIAGNOSTIC GRIFOLS SA
Model
210393
Catalog number
210393
Device description
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 as a control microtube. For use with the DG Gel System.For in vitro diagnostic use.
Published
2020-11-16
Public version status
Update
Distribution status
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08437014205008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437014205008084370142050088437014205008

GMDN Terms#

Term, Definition table
TermDefinition
ABO/Rh(D)/Kell multiple blood grouping IVD, kit, agglutinationA collection of immunoglobulins capable of binding to specific antigenic determinants and intended to be used together in testing a clinical specimen for a combination of one or multiple ABO system, Rh(D) [RH001] and Kell [KEL001] red blood cell antigens, using an agglutination method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
463625602
Device count
1
Kit
true
Lot or batch
true
Expiration 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
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
08437014205169DG Therm2137342137342016-09-06

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
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
08437014205619DG Reader NetDIAGNOSTIC GRIFOLS SAKSZ2019-11-27