Access Progesterone II Sample Diluent C81798

GUDID 15099590752705

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.

Beckman Coulter, Inc.

Progesterone IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 15099590752705
• NIH Device Record Key: 4d5082ed-c038-4e3c-b16d-48276e2b7266
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Progesterone II Sample Diluent
• Version Model Number: C81798
• Catalog Number: C81798
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590752705 [Primary]

FDA Product Code

• JLS: Radioimmunoassay, Progesterone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-11
• Device Publish Date: 2024-03-01

Devices Manufactured by Beckman Coulter, Inc.

• 15099590754488 - Access Total T4 II: 2025-09-29 The Access Total T4 II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of tota
• 15099590754495 - Access Total T4 II Calibrators: 2025-09-29 The Access Total T4 II Calibrators are intended to calibrate the Access Total T4 II assay for the quantitative determination of
• 15099590224301 - Access Vitamin B12: 2025-09-17 The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of vita
• 15099590750312 - Cellmek: 2025-09-10 Cellmek SPS
• 15099590754013 - DxFLEX: 2025-09-10 DxFLEX Flow Cytometer
• 15099590701673 - Access Hybritech PSA: 2025-06-09 The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of to
• 15099590701680 - Access Hybritech free PSA: 2025-06-09 The Access Hybritech free PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination
• 15099590763626 - Access Syphilis Reagent: 2025-05-15 The Access Syphilis assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative detection of total antibo