Access Progesterone

Basic Information

• Brand Name: Access Progesterone
• Primary DI: 15099590231378
• Version / Model: 33550
• Catalog Number: 33550
• Company Name: Beckman Coulter, Inc.
• Labeler DUNS: 008254708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-03
• Public Version: 1
• Public Version Date: 2021-09-13
• Public Version Status: New
• Public Device Record Key: ec6d6af6-0186-4a2a-8df7-893dd27a0cb1

Device Description

The Access Progesterone assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of progesterone levels in human serum using the Access Immunoassay Systems.

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	15099590231378	GS1