ALBAzyme™ Papain Solution Kit

Basic Information

• Brand Name: ALBAzyme™ Papain Solution Kit
• Primary DI: 05060242471223
• Version / Model: Z317U
• Company Name: ALBA BIOSCIENCE LIMITED
• Labeler DUNS: 516536641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-29
• Public Version: 4
• Public Version Date: 2022-03-31
• Public Version Status: Update
• Public Device Record Key: b7c3e3df-22cd-48ac-b059-41e42d384203

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KSK	Solution, Stabilized Enzyme	Hematology	864.9400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52728	Papain immunohaematology reagent IVD	A substance or reactant that is a papain enzyme solution intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate red cell agglutination reactions by enzymatically digesting red cell membrane proteins and removing sialic acid residues.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060242471223	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]