ALBAhance LISS Additive Reagent

GUDID 05060242471544

ALBAhance LISS Additive Reagent.

ALBA BIOSCIENCE LIMITED

Low ionic-strength salt solution (LISS) immunohaematology reagent IVD

• Primary Device ID: 05060242471544
• NIH Device Record Key: 40b4435b-df5e-42a4-808c-68b2f48c80ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALBAhance LISS Additive Reagent
• Version Model Number: Z333U
• Company DUNS: 516536641
• Company Name: ALBA BIOSCIENCE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441314456261
• Email: vittorio.borromeo@quotientbd.c
• Phone: +441314456261
• Email: vittorio.borromeo@quotientbd.com
• Phone: +441314456261
• Email: vittorio.borromeo@quotientbd.com
• Phone: +441314456261
• Email: vittorio.borromeo@quotientbd.com
• Phone: +441314456261
• Email: vittorio.borromeo@quotientbd.com
• Phone: +441314456261
• Email: vittorio.borromeo@quotientbd.com
• Phone: +441314456261
• Email: vittorio.borromeo@quotientbd.com
• Phone: +441314456261
• Email: vittorio.borromeo@quotientbd.com
• Phone: +441314456261
• Email: vittorio.borromeo@quotientbd.com
• Phone: +441314456261
• Email: vittorio.borromeo@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com
• Phone: +441313573333
• Email: Victoria.Vanhoutte@alivedx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060242471117 [Package]; Package: Carton [10 Units]; In Commercial Distribution
GS1	05060242471544 [Primary]

FDA Product Code

• KSK: Solution, Stabilized Enzyme

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-28
• Device Publish Date: 2014-11-14

Devices Manufactured by ALBA BIOSCIENCE LIMITED

• 05060242477959 - ALBA Elution Kit: 2023-10-23 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™II: 2022-03-31 FETALSCREEN™ is a Qualitative Screening Test for RhD (Rho) positive fetal red blood cells in the maternal circulation.
• 10758750013005 - ORTHOTM Sera Anti-Fya: 2022-03-31 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-Fyb: 2022-03-31 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-Jka: 2022-03-31 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-Jkb: 2022-03-31 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-S: 2022-03-31 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-s: 2022-03-31 The Anti-s reagent (Anti-MNS4) is for the qualitative in vitro detection of human s positive red blood cells by the indirect ant