Access Hyritech free PSA Calibrators 37215

GUDID H628372151

The Access Hybritech free PSA Calibrators are intended to calibrate the Access Hybritech free PSA assay for the quantitative determination of free PSA levels in human serum using the Access Immunoassay Systems.

Beckman Coulter, Inc.

Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: H628372151
• NIH Device Record Key: 0833a800-1b13-4558-9cd7-790722675ae8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Hyritech free PSA Calibrators
• Version Model Number: 37215
• Catalog Number: 37215
• 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: true
• 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
HIBCC	H628372151 [Primary]

FDA Product Code

• MTG: Test,Prostate Specific Antigen,Free,(Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2014-09-16

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