IH-AbID

Basic Information

• Brand Name: IH-AbID
• Primary DI: 03610522136421
• Version / Model: 12010902
• Catalog Number: 12010902
• 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: 2022-12-13
• Public Version: 1
• Public Version Date: 2022-12-21
• Public Version Status: New
• Public Device Record Key: 8191da14-e2af-4184-923b-f78f9d78dd97

Device Description

IH-AbID Integrated Antibody Identification Software is an optional software module for IHCom that provides the user with guidance and information on the identification of antibodies to red blood cell antigens subsequent to the immunohematology testing with the IH-system. The IH-AbID module graphically displays the ruling out of antibodies to red blood cell antigens by reproducing the same logic techniques of antibody identification used in blood transfusion laboratories. For use by trained laboratory personnel, in a (blood transfusion) laboratory environment.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MMH	Blood Establishment Computer Software And Accessories	Hematology	864.9165	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43472	Laboratory instrument/analyser application software IVD	An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03610522136421	GS1

Premarket Submissions

Submission Number	Supplement Number
BK220769	0