Access Progesterone II Sample Diluent

Basic Information

• Brand Name: Access Progesterone II Sample Diluent
• Primary DI: 15099590752705
• Version / Model: C81798
• Catalog Number: C81798
• Company Name: Beckman Coulter, Inc.
• Labeler DUNS: 008254708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-01
• Public Version: 1
• Public Version Date: 2024-03-11
• Public Version Status: New
• Public Device Record Key: 4d5082ed-c038-4e3c-b16d-48276e2b7266

Device Description

The Access Progesterone II Sample Diluent is intended for use with the Access Progesterone II assay to dilute samples containing progesterone concentrations greater than the S5 calibrator on the automated Access 2 Immunoassay System and 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: Yes
• 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
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	862.1620	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54322	Progesterone IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of progesterone in a clinical specimen, using a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15099590752705	GS1