FDA.reportPublic FDA data

ALBAzyme™ Papain Solution Kit

Primary DI
05060242471223
Brand
ALBAzyme™ Papain Solution Kit
Company
ALBA BIOSCIENCE LIMITED
Model
Z317U
Device description
ALBAzyme™ Papain Solution Kit is used for the preparation and testing of papainized red blood cells.
Published
2017-03-29
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
KSKSolution, Stabilized Enzyme

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSKSolution, Stabilized EnzymeHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060242471223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060242471223050602424712235060242471223

GMDN Terms#

Term, Definition table
TermDefinition
Papain immunohaematology reagent IVDA substance or reactant that is a papain enzyme solution intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate red cell agglutination reactions by enzymatically digesting red cell membrane proteins and removing sialic acid residues.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441314456261vittorio.borromeo@quotientbd.c
+41225458274olivia.baud@quotientbd.com
+441313573333Victoria.Vanhoutte@alivedx.com

Regulatory Flags#

DUNS number
516536641
Device count
1
Kit
true
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
23661562105452PapainDIAGASTKSK2018-05-01
07611969952199IH-PapainBio-Rad Medical Diagnostics GmbHKSK2018-04-05
10758750030330ORTHOTM Sera Papain ALBA BIOSCIENCE LIMITEDKSK2017-08-30
10888234000891Gamma-QuinIMMUCOR, INC.KSK2016-04-19
10888234001010W.A.R.M.IMMUCOR, INC.KSK2016-04-18
10888234000709GammaZyme-FIMMUCOR, INC.KSK2016-04-15
10888234000716GammaZyme-BIMMUCOR, INC.KSK2016-04-15
10888234000990Freeze Dried PapainIMMUCOR, INC.KSK2016-04-15
23661562173307Beckman Coulter® PK® Systems BromelinDIAGASTKSK2015-09-18
05060242471544ALBAhance LISS Additive ReagentALBA BIOSCIENCE LIMITEDKSK2014-11-14