ALBAcyte IgG Sensitized Red Blood Cells

GUDID 05060242471162

ALBAcyte IgG Sensitized Red Blood Cells for control of the direct and indirect antiglobulin test.

ALBA BIOSCIENCE LIMITED

Immunoglobulin G (IgG) sensitized reagent red blood cell IVD, control
Primary Device ID05060242471162
NIH Device Record Keyf84e269f-8983-4a82-9de8-79546292c5fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameALBAcyte IgG Sensitized Red Blood Cells
Version Model NumberZ441U
Company DUNS516536641
Company NameALBA BIOSCIENCE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+441314456261
Emailvittorio.borromeo@quotientbd.c
Phone+441314456261
Emailvittorio.borromeo@quotientbd.com
Phone+441314456261
Emailvittorio.borromeo@quotientbd.com
Phone+441314456261
Emailvittorio.borromeo@quotientbd.com
Phone+441314456261
Emailvittorio.borromeo@quotientbd.com
Phone+441314456261
Emailvittorio.borromeo@quotientbd.com
Phone+441314456261
Emailvittorio.borromeo@quotientbd.com
Phone+441314456261
Emailvittorio.borromeo@quotientbd.com
Phone+441314456261
Emailvittorio.borromeo@quotientbd.com
Phone+441314456261
Emailvittorio.borromeo@quotientbd.com
Phone+441314456261
Emailvittorio.borromeo@quotientbd.com
Phone+441314456261
Emailvittorio.borromeo@quotientbd.com
Phone+441314456261
Emailvittorio.borromeo@quotientbd.com
Phone+441314456261
Emailvittorio.borromeo@quotientbd.com
Phone+441314456261
Emailvittorio.borromeo@quotientbd.com
Phone+441314456261
Emailvittorio.borromeo@quotientbd.com
Phone+41225458274
Emailolivia.baud@quotientbd.com
Phone+41225458274
Emailolivia.baud@quotientbd.com
Phone+41225458274
Emailolivia.baud@quotientbd.com
Phone+41225458274
Emailolivia.baud@quotientbd.com
Phone+41225458274
Emailolivia.baud@quotientbd.com
Phone+41225458274
Emailolivia.baud@quotientbd.com
Phone+41225458274
Emailolivia.baud@quotientbd.com
Phone+41225458274
Emailolivia.baud@quotientbd.com
Phone+41225458274
Emailolivia.baud@quotientbd.com
Phone+41225458274
Emailolivia.baud@quotientbd.com
Phone+41225458274
Emailolivia.baud@quotientbd.com
Phone+41225458274
Emailolivia.baud@quotientbd.com
Phone+41225458274
Emailolivia.baud@quotientbd.com
Phone+41225458274
Emailolivia.baud@quotientbd.com
Phone+41225458274
Emailolivia.baud@quotientbd.com
Phone+41225458274
Emailolivia.baud@quotientbd.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105060242471162 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSFKit, Quality Control For Blood Banking Reagents

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-28
Device Publish Date2016-09-24

Devices Manufactured by ALBA BIOSCIENCE LIMITED

05060242477959 - ALBA Elution Kit2023-10-23 The ALBA Elution Kit is intended for use in the acid elution of antibodies from intact red blood cells to allow further detectio
10758750006144 - FETALSCREEN™II2022-03-31 FETALSCREEN™ is a Qualitative Screening Test for RhD (Rho) positive fetal red blood cells in the maternal circulation.
10758750013005 - ORTHOTM Sera Anti-Fya2022-03-31 The Anti-Fya reagent (Anti-FY1) is for the qualitative in vitro detection of human Fya positive red blood cells by the indirect
10758750013012 - ORTHOTM Sera Anti-Fyb2022-03-31 The Anti-Fyb reagent (Anti-FY2) is for the qualitative in vitro detection of human Fyb positive red blood cells by the indirect
10758750013029 - ORTHOTM Sera Anti-Jka2022-03-31 The Anti-Jka reagent (Anti-JK1) is for the qualitative in vitro detection of human Jka positive red blood cells by the direct ag
10758750013036 - ORTHOTM Sera Anti-Jkb2022-03-31 The Anti-Jkb reagent (Anti-JK2) is for the qualitative in vitro detection of human Jkb positive red blood cells by the direct ag
10758750013043 - ORTHOTM Sera Anti-S2022-03-31 The Anti-S reagent (Anti-MNS3) is for the qualitative in vitro detection of human S positive red blood cells by the indirect ant
10758750013050 - ORTHOTM Sera Anti-s2022-03-31 The Anti-s reagent (Anti-MNS4) is for the qualitative in vitro detection of human s positive red blood cells by the indirect ant

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