ALBAcheck - BGS Monoclonal Control

GUDID 05060242472459

ALBAcheck - BGS Monoclonal Control is designed to be used as a negative control in conjunction with Alba Bioscience Limited monoclonal blood grouping reagents (where referenced in the reagent IFU).

ALBA BIOSCIENCE LIMITED

Antisera matrix (non-reactive) IVD, control

• Primary Device ID: 05060242472459
• NIH Device Record Key: 9c2bddbe-8bc4-409e-87f0-51c09e81c4d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALBAcheck - BGS Monoclonal Control
• Version Model Number: Z271U
• Company DUNS: 516536641
• Company Name: ALBA BIOSCIENCE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441312920445
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060242471513 [Previous]
GS1	05060242472442 [Package]; Contains: 05060242472473; Package: [10 Units]; In Commercial Distribution
GS1	05060242472459 [Package]; Contains: 05060242472473; Package: [1 Units]; In Commercial Distribution
GS1	05060242472473 [Primary]

FDA Product Code

• KSF: Kit, Quality Control For Blood Banking Reagents

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: 2020-06-29
• Device Publish Date: 2020-06-19

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