FDA.reportPublic FDA data

Anti-K (KEL1)

Primary DI
23661562105339
Brand
Anti-K (KEL1)
Company
DIAGAST
Model
210533
Catalog number
210533
Device description
Blood Grouping Reagent, Anti-K (Human/Murine Monoclonal) (MS56) - This reagent is designed to determine the presence of the blood group antigen K on the surface of human red blood cells by manual tube method.
Published
2018-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
23661562105339PrimaryGS10
13661562105332Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2366156210533923661562105339
1366156210533213661562105332

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
381527001
Device count
4
Lot or batch
true
Serial number
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
23661562173192Beckman Coulter® PK® Systems Anti-e (P3GD512+MS63)17319173192015-09-04
23661562173178Beckman Coulter® PK® Systems Control17317173172016-01-12
23661562173307Beckman Coulter® PK® Systems Bromelin17330173302015-09-18
23661562105469Anti-Human Globulin Anti-IgG,-C3d, polyspecific - Green2105462105462018-05-01
23661562105476Anti-Human Globulin Anti-IgG - Green2105472105472018-05-01
23661562105490Anti-Human Globulin Anti-IgG - Clear2105492105492018-05-01
23661562105506Anti-Human Globulin Anti-IgG,-C3d, polyspecific - Clear2105502105502018-05-01
23661562495584Beckman Coulter® PK® Systems Anti-e (P3GD512+MS16+MS21+MS63)B49558B495582020-10-20
23661562105209Anti-A (AB01)2105202105202018-05-01
23661562105216Anti-B (AB02)2105212105212018-05-01
23661562105223Anti-A,B (AB03)2105222105222018-05-01
23661562105247Anti-D (RH1) IgG2105242105242018-05-01
23661562105254Anti-D (RH1) IgM2105252105252018-05-01
23661562105278Anti-C (RH2)2105272105272018-05-01
23661562105285Anti-c (RH4)2105282105282018-05-01
23661562105292Anti-E (RH3)2105292105292018-05-01
23661562105308Anti-e (RH5)2105302102302018-05-01
23661562105315Anti-Fya (FY1)2105312105312018-05-01
23661562105322Anti-Fyb (FY2)2105322105322018-05-01
23661562105346Anti-Jka (JK1)2105342105342018-05-01