FDA.reportPublic FDA data

ALBAhance PEG

Primary DI
05060242471537
Brand
ALBAhance PEG
Company
ALBA BIOSCIENCE LIMITED
Model
Z312U
Device description
ALBAhance PEG for the potentiation of indirect antiglobulin tests.
Published
2014-11-14
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
KSGMedia, Potentiating For In Vitro Diagnostic Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSGMedia, Potentiating For In Vitro Diagnostic UseHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060242471100PackageGS110In Commercial Distribution
05060242471537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060242471100050602424711005060242471100
05060242471537050602424715375060242471537

GMDN Terms#

Term, Definition table
TermDefinition
Polyethylene glycol (PEG) immunohaematology reagent IVDA substance or reactant that is a polyethylene glycol (PEG) solution, intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate agglutination reactions by reducing the zeta potential of red blood cells.

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
Premarket exempt
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
05060242477959ALBA Elution KitALBA BIOSCIENCE LIMITEDKSG2023-10-13
07611969964505IH-Titration RackBio-Rad Medical Diagnostics GmbHKSG2022-03-09
07611969952205IH-Titration SolutionBio-Rad Medical Diagnostics GmbHKSG2022-03-03
00858400005107PEGAmerican National Red CrossKSG2018-09-17
00858400005121LISSAmerican National Red CrossKSG2018-09-17
10858400005104PEGAMERICAN NATIONAL RED CROSSKSG2018-09-17
10858400005128LISSAMERICAN NATIONAL RED CROSSKSG2018-09-17
23661562105445LISSDIAGASTKSG2018-05-01
07611969952182IH-LISS SolutionBio-Rad Medical Diagnostics GmbHKSG2018-04-05
07611969069934IH-LISS RackBio-Rad Medical Diagnostics GmbHKSG2017-01-20
00858352006023ELUclear HEMO BIOSCIENCE INCKSG2016-09-27
10758750006038MTSMICRO TYPING SYSTEMS, INCKSG2016-08-24
10758750006045MTSMICRO TYPING SYSTEMS, INCKSG2016-08-24
10758750007820ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.KSG2016-08-24
10758750007837ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.KSG2016-08-24
10888234000167ImmuAddIMMUCOR, INC.KSG2016-04-15
10888234000235Bovine Albumin Solution 22%IMMUCOR, INC.KSG2016-04-15
10888234001775Gamma LO-IONIMMUCOR, INC.KSG2016-04-15
10888234001782Gamma PeGIMMUCOR, INC.KSG2016-04-15
10888234001799Gamma PeGIMMUCOR, INC.KSG2016-04-15
10888234001805Gamma N-HANCEIMMUCOR, INC.KSG2016-04-15
10888234001812Gamma N-HANCEIMMUCOR, INC.KSG2016-04-15
10888234000860Gamma ELU-KIT IIIMMUCOR, INC.KSG2016-04-14
10888234000877Gamma EGA KitIMMUCOR, INC.KSG2016-04-14
05060242471520Bovine Serum Albumin 22%ALBA BIOSCIENCE LIMITEDKSG2014-11-14