ACCESS HIV Ag/Ab combo QC

Basic Information

• Brand Name: ACCESS HIV Ag/Ab combo QC
• Primary DI: 15099590745172
• Version / Model: C39452
• Catalog Number: C39452
• Company Name: Beckman Coulter, Inc.
• Labeler DUNS: 008254708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-15
• Public Version: 1
• Public Version Date: 2024-03-25
• Public Version Status: New
• Public Device Record Key: 60e1145e-1536-425c-9c25-621cb1a17c05

Device Description

The Access HIV Ag/Ab combo QC is intended for monitoring system performance of the Access HIV Ag/Ab combo assay. The Access HIV Ag/Ab combo QC is for use on the DxI 9000 Access Immunoassay Analyzer.

Device Characteristics

• Single Use: No
• 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: Yes
• 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
MJY	Kit, Serological, Negative Control	Clinical Chemistry	862.1660	1
MJX	Kit, Serological, Positive Control	Clinical Chemistry	862.1660	1
MJZ	Kit, Direct Antigen, Positive Control	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48449	HIV1/HIV2 antigen/antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from and antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15099590745172	GS1