Anti-human Globulin Anti-IgG, -C3d Polyspecific Rabbit/Murine Monoclonal

GUDID 05060242472374

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.

ALBA BIOSCIENCE LIMITED

Polyspecific antihuman globulin/complement IVD, antibody, agglutination
Primary Device ID05060242472374
NIH Device Record Key0bf6d6b2-f808-47fa-821b-c30f33e8e667
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-human Globulin Anti-IgG, -C3d Polyspecific Rabbit/Murine Monoclonal
Version Model NumberZ351U
Company DUNS516536641
Company NameALBA BIOSCIENCE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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+441312920445
Emailvittorio.borromeo@quotientbd.com
Phone+441312920445
Emailvittorio.borromeo@quotientbd.com
Phone+441312920445
Emailvittorio.borromeo@quotientbd.com
Phone+441312920445
Emailvittorio.borromeo@quotientbd.com
Phone+441312920445
Emailvittorio.borromeo@quotientbd.com
Phone+441312920445
Emailvittorio.borromeo@quotientbd.com
Phone+441312920445
Emailvittorio.borromeo@quotientbd.com
Phone+441312920445
Emailvittorio.borromeo@quotientbd.com
Phone+441312920445
Emailvittorio.borromeo@quotientbd.com
Phone+441312920445
Emailvittorio.borromeo@quotientbd.com
Phone+441312920445
Emailvittorio.borromeo@quotientbd.com
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
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
GS105060242472367 [Primary]
GS105060242472374 [Package]
Contains: 05060242472367
Package: [1 Units]
In Commercial Distribution
GS105060242472381 [Package]
Contains: 05060242472367
Package: [3 Units]
In Commercial Distribution
GS105060242472398 [Package]
Contains: 05060242472367
Package: [10 Units]
In Commercial Distribution

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-28
Device Publish Date2020-02-20

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.