FDA.reportPublic FDA data

Anti-Human Globulin Anti-IgG, -C3d Polyspecific Rabbit/Murine Monoclonal (Green)

Primary DI
05060242471575
Brand
Anti-Human Globulin Anti-IgG, -C3d Polyspecific Rabbit/Murine Monoclonal (Green)
Company
ALBA BIOSCIENCE LIMITED
Model
Z350U
Device description
Anti-Human Globulin, Anti-IgG,-C3d; Polyspecific is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with IgG and/or C3b and/or C3d components. Anti-Human Globulin, Anti-IgG,-C3d; Polyspecific is intended for use in the indirect antiglobulin test to detect the in vitro coating of human red blood cells with IgG and/or C3b and/or C3d components.
Published
2018-02-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060242471551PackageGS11In Commercial Distribution
05060242471568PackageGS13In Commercial Distribution
05060242471575PackageGS110In Commercial Distribution
05060242471636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060242471551050602424715515060242471551
05060242471568050602424715685060242471568
05060242471575050602424715755060242471575
05060242471636050602424716365060242471636

GMDN Terms#

Term, Definition table
TermDefinition
Polyspecific antihuman globulin/complement IVD, antibody, agglutinationOne or multiple immunoglobulins capable of binding to all classes of human immunoglobulin antibodies and/or complement components when fixed to red blood cells. This solution is intended to be used in immunohaematological testing of a clinical specimen to detect red blood cell sensitization by human immunoglobulin and/or complement components, using an agglutination technique.

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
+4401312920445vittorio.borromeo@quotientbd.com
+41225458274olivia.baud@quotientbd.com
+441313573333Victoria.Vanhoutte@alivedx.com

Regulatory Flags#

DUNS number
516536641
Device count
1
DM exempt
false
Premarket exempt
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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05060242472664Ortho™ BioClone™ PLUS Anti-D blend61411242026-06-09
05060242473067Ortho™ Confidence Manual System61411232026-03-12
05060242471353ALBAsure QC KitZ481U2015-07-15
05060242472817Ortho™ BioClone™ PLUS Anti-Human Globulin IgG61411302026-04-10
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05060242472923Ortho™ BioClone™ PLUS Anti-N61411272026-04-10
05060242477959ALBA Elution KitZ313U2023-10-13
05060242472596ORTHO® Elution Kit632444442025-12-04
05060242471636Anti-Human Globulin Anti-IgG, -C3d Polyspecific Rabbit/Murine Monoclonal (Green)Z350U2018-02-16
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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
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