FDA.reportPublic FDA data

ALBAclone Anti-Jkb (Monoclonal)

Primary DI
05060242472510
Brand
ALBAclone Anti-Jkb (Monoclonal)
Company
ALBA BIOSCIENCE LIMITED
Model
Z168U
Device description
This Anti-Jkb reagent is for the in vitro detection and identification of the human Jkb blood group antigen by direct agglutination.
Published
2021-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060242472527PackageGS11In Commercial Distribution
05060242472534PackageGS13In Commercial Distribution
05060242472510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060242472527050602424725275060242472527
05060242472534050602424725345060242472534
05060242472510050602424725105060242472510

GMDN Terms#

Term, Definition table
TermDefinition
Anti-Jk^b 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 Jk^b [JK002] red blood cell antigens from the Kidd system, using an agglutination method.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+441313573333Victoria.Vanhoutte@alivedx.com

Regulatory Flags#

DUNS number
516536641
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060242472817Ortho™ BioClone™ PLUS Anti-Human Globulin IgG61411302026-04-10
05060242472855Ortho™ BioClone™ PLUS Anti-Human Globulin Anti-IgG (Rabbit) (Green)61411312026-04-10
05060242472923Ortho™ BioClone™ PLUS Anti-N61411272026-04-10
05060242473067Ortho™ Confidence Manual System61411232026-03-12
05060242477959ALBA Elution KitZ313U2023-10-13
05060242472596ORTHO® Elution Kit632444442025-12-04
05060242471636Anti-Human Globulin Anti-IgG, -C3d Polyspecific Rabbit/Murine Monoclonal (Green)Z350U2018-02-16
05060242472473ALBAcheck - BGS Monoclonal ControlZ271U2020-06-19
05060242471056ALBAsera Anti-WraZ231U2014-11-14
05060242471445ALBAclone Anti-A,BZ023U2014-11-28
05060242471483ALBAclone Anti-D alphaZ031U2014-11-14
05060242472367Anti-human Globulin Anti-IgG, -C3d Polyspecific Rabbit/Murine MonoclonalZ351U2020-02-20
05060242472404Anti-Human Globulin Anti-IgG (Rabbit) (Green)Z357U2020-02-20
05060242472480ALBAclone Anti-Jka (Monoclonal) Z164U2021-02-01
05060242471711ALBAclone Anti-Jkb (Monoclonal)Z166U2019-06-21
05060242471032ALBAclone Anti-LubZ223U2014-11-14
05060242471704ALBAclone Anti-Jka (Monoclonal)Z162U2019-06-21
05060242470998ALBAclone Anti-MZ171U2014-11-14
05060242471650ALBAclone® Anti-CwZ106U2018-06-05
05060242471698ALBAclone Anti-Fya (Monoclonal IgG)Z152U2019-06-27