ALBA Elution Kit

GUDID 05060242477959

The ALBA Elution Kit is intended for use in the acid elution of antibodies from intact red blood cells to allow further detection and/or identification. It is intended for professional use within a blood donor or clinical laboratory environment to perform acid elution of antibodies relating to transfusion in the general population. This pre-analytical procedure is performed manually. The ALBA Elution Kit is an accessory for sample preparation only and does not return diagnostic results for an analyte

ALBA BIOSCIENCE LIMITED

Red cell antibody eluting IVD, kit

• Primary Device ID: 05060242477959
• NIH Device Record Key: e3c17f01-0ffe-421f-b5d0-f5a6ad08e388
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALBA Elution Kit
• Version Model Number: Z313U
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• 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: +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: +41225458274
• Email: Olivia.Baud@quotientbd.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060242477959 [Primary]

FDA Product Code

• KSG: Media, Potentiating For In Vitro Diagnostic Use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-23
• Device Publish Date: 2023-10-13

Devices Manufactured by ALBA BIOSCIENCE LIMITED

• 05060242477959 - ALBA Elution Kit: 2023-10-23The ALBA Elution Kit is intended for use in the acid elution of antibodies from intact red blood cells to allow further detection and/or identification. It is intended for professional use within a blood donor or clinical laboratory environment to perform acid elution of antibodies relating to transfusion in the general population. This pre-analytical procedure is performed manually. The ALBA Elution Kit is an accessory for sample preparation only and does not return diagnostic results for an analyte
• 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