FDA.reportPublic FDA data

FETALSCREEN™II

Primary DI
10758750006144
Brand
FETALSCREEN™II
Company
ALBA BIOSCIENCE LIMITED
Model
Z488
Device description
FETALSCREEN™ is a Qualitative Screening Test for RhD (Rho) positive fetal red blood cells in the maternal circulation.
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
MTIKit, Cell Screening, Fetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MTIKit, Cell Screening, FetalUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10758750006144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075875000614410758750006144

GMDN Terms#

Term, Definition table
TermDefinition
Foetal blood group genotyping IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used to evaluate a clinical specimen to diagnose, monitor or predict haemolytic disease of the newborn based on one or multiple blood group genotypes. The blood group genotypes to be assayed may include Rhesus, Kell, Duffy and/or Kidd blood groups.

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
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

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05060242472855Ortho™ BioClone™ PLUS Anti-Human Globulin Anti-IgG (Rabbit) (Green)61411312026-04-10
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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