FDA.reportPublic FDA data

ALBAclone Anti-Jka (Monoclonal)

Primary DI
05060242472480
Brand
ALBAclone Anti-Jka (Monoclonal)
Company
ALBA BIOSCIENCE LIMITED
Model
Z164U
Device description
This Anti-Jka reagent is for the in vitro detection and identification of the human Jka 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
05060242472497PackageGS11In Commercial Distribution
05060242472503PackageGS13In Commercial Distribution
05060242472480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060242472497050602424724975060242472497
05060242472503050602424725035060242472503
05060242472480050602424724805060242472480

GMDN Terms#

Term, Definition table
TermDefinition
Anti-Jk^a 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^a [JK001] red blood cell antigens from the Kidd system, using an agglutination method.

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
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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
05060242472510ALBAclone Anti-Jkb (Monoclonal) Z168U2021-02-01
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
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