Access Progesterone II Calibrators C78021

GUDID 15099590752699

The Access Progesterone II Calibrators are intended to calibrate the Access Progesterone II assay for the quantitative determination of progesterone levels in human serum and plasma (lithium heparin) on the automated Access 2 Immunoassay System and DxI 9000 Access Immunoassay Analyzer.

Beckman Coulter, Inc.

Progesterone IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 15099590752699
• NIH Device Record Key: 7d7927dd-6fd2-4e45-95c5-f21078ab4a9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Progesterone II Calibrators
• Version Model Number: C78021
• Catalog Number: C78021
• 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	15099590752699 [Primary]

FDA Product Code

• JIS: Calibrator, Primary

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

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