ALBAzyme™ Papain Solution Kit

GUDID 05060242471223

ALBAzyme™ Papain Solution Kit is used for the preparation and testing of papainized red blood cells.

ALBA BIOSCIENCE LIMITED

Papain immunohaematology reagent IVD Papain immunohaematology reagent IVD Papain immunohaematology reagent IVD Papain immunohaematology reagent IVD Papain immunohaematology reagent IVD Papain immunohaematology reagent IVD Papain immunohaematology reagent IVD Papain immunohaematology reagent IVD Papain immunohaematology reagent IVD Papain immunohaematology reagent IVD Papain immunohaematology reagent IVD Papain immunohaematology reagent IVD Papain immunohaematology reagent IVD Papain immunohaematology reagent IVD Papain immunohaematology reagent IVD Papain immunohaematology reagent IVD Papain immunohaematology reagent IVD

• Primary Device ID: 05060242471223
• NIH Device Record Key: b7c3e3df-22cd-48ac-b059-41e42d384203
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALBAzyme™ Papain Solution Kit
• Version Model Number: Z317U
• 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: 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: +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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060242471223 [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: 3
• Public Version Date: 2019-01-28
• Device Publish Date: 2017-03-29

Devices Manufactured by ALBA BIOSCIENCE LIMITED

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• 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