FDA.reportPublic FDA data

ORTHOTM Sera Papain

Primary DI
10758750030330
Brand
ORTHOTM Sera Papain
Company
ALBA BIOSCIENCE LIMITED
Model
6904840
Device description
For in vitro diagnostic use only.For use as an enzyme solution with ORTHO™ Sera Anti-Lea, Anti-Leb, Anti-Jka and Anti-Jkb Blood Grouping Reagents.The ORTHO™ Sera Papain is used to enhance reactivity of ORTHO™ Sera red blood cell antigen typing reagents and redblood cells when used in in vitro immunohematology assays.
Published
2017-08-30
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
10758750030330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075875003033010758750030330

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.

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
+41225458274olivia.baud@quotientbd.com
+441313573333Victoria.Vanhoutte@alivedx.com

Regulatory Flags#

DUNS number
516536641
Device count
1
Lot or batch
true
Expiration date on label
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
05060242471223ALBAzyme™ Papain Solution KitALBA BIOSCIENCE LIMITEDKSK2017-03-29
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