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

• 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

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• 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