Erytype S ABO Confirm

Basic Information

• Brand Name: Erytype S ABO Confirm
• Primary DI: 07611969965670
• Version / Model: 806130100
• Catalog Number: 806130100
• Company Name: Bio-Rad Medical Diagnostics GmbH
• Labeler DUNS: 312576506
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-07
• Public Version: 3
• Public Version Date: 2021-10-19
• Public Version Status: Update
• Public Device Record Key: 11984af1-5c35-4135-85ec-47763455ae2c

Device Description

Blood Grouping Reagent; Erytype S ABO Confirm; Microplate for ABO donor unit confirmation with TANGO instruments; contains Anti-A (A003) and Anti-B (B005); 10 Plates

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
45308	ABO/Rh multiple blood grouping IVD, kit, agglutination	A collection of immunoglobulins capable of binding to specific antigenic determinants and intended to be used together in testing a clinical specimen for a combination of multiple ABO system and Rh group 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	07611969965670	GS1

Customer Contacts

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

Storage Conditions

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