FDA.reportPublic FDA data

DG Gel 8 Anti-K

Primary DI
08436583731048
Brand
DG Gel 8 Anti-K
Company
DIAGNOSTIC GRIFOLS SA
Model
210225
Catalog number
210225
Device description
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.For use with the DG Gel System. For in vitro diagnostic use.
Published
2022-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08436583731048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436583731048084365837310488436583731048

GMDN Terms#

Term, Definition table
TermDefinition
Anti-K (KEL001) red blood cell grouping IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for K [KEL001] red blood cell antigens from the Kell system, using an agglutination method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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
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