Access Progesterone Calibrators

Basic Information

• Brand Name: Access Progesterone Calibrators
• Primary DI: 15099590231361
• Version / Model: 33555
• Catalog Number: 33555
• 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: 9a9ea783-b294-4c18-9d8e-b6c66f5cccd8

Device Description

The Access Progesterone Calibrators are intended to calibrate the Access Progesterone assay 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
JIS	Calibrator, Primary	Clinical Chemistry	862.1150	2

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	15099590231361	GS1