ALBAcyte IgG Sensitized Red Blood Cells II

GUDID 05060242472336

These IgG Sensitized Red Blood Cells are for the control of the Indirect Antiglobulin Test (IAT) and Direct Antiglobulin Test (DAT).

ALBA BIOSCIENCE LIMITED

Immunoglobulin G (IgG) sensitized reagent red blood cell IVD, control
Primary Device ID05060242472336
NIH Device Record Key7ccf28d2-3526-4fbb-a105-fde112498342
Commercial Distribution StatusIn Commercial Distribution
Brand NameALBAcyte IgG Sensitized Red Blood Cells II
Version Model NumberZ443U
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+441312920445
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105060242472329 [Primary]
GS105060242472336 [Package]
Contains: 05060242472329
Package: [1 Units]
In Commercial Distribution
GS105060242472343 [Package]
Contains: 05060242472329
Package: [3 Units]
In Commercial Distribution
GS105060242472350 [Package]
Contains: 05060242472329
Package: [10 Units]
In Commercial Distribution

FDA Product Code

KSFKit, Quality Control For Blood Banking Reagents

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-20
Device Publish Date2019-05-10

Devices Manufactured by ALBA BIOSCIENCE LIMITED

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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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