Access Testosterone 33560

GUDID 15099590231347

The Access Testosterone assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total testosterone levels

Beckman Coulter, Inc.

Free testosterone IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 15099590231347
• NIH Device Record Key: fee9f656-c6c8-42f9-8b7c-238b5a7b76ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Testosterone
• Version Model Number: 33560
• Catalog Number: 33560
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	15099590231347 [Primary]

FDA Product Code

• CDZ: Radioimmunoassay, Testosterones And Dihydrotestosterone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-04-09
• Device Publish Date: 2016-09-09

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