ALBAlect Anti-A1 Dolichos biflorus Blood Grouping Lectin

Basic Information

• Brand Name: ALBAlect Anti-A1 Dolichos biflorus Blood Grouping Lectin
• Primary DI: 05060242471063
• Version / Model: Z241U
• Company Name: ALBA BIOSCIENCE LIMITED
• Labeler DUNS: 516536641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2022-03-31
• Public Version Status: Update
• Public Device Record Key: 854261b4-5e1f-4af8-a6bb-afdc04ca0233

Device Description

For the in vitro detection and identification of human A1 red blood cellls

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• 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
KSI	Lectins And Protectins	Hematology	864.9550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46441	Anti-A1 red blood cell grouping IVD, lectin	Lectin molecules extracted from Dolichos biflorus, capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for group A1 [ABO004] red blood cell antigens, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060242471063	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius