Access Hybritech PSA Calibrators 37205

GUDID H628372051

The Access Hybritech PSA Calibrators are intended to calibrate the Access Hybritech PSA assay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems.

Beckman Coulter, Inc.

Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: H628372051
• NIH Device Record Key: 1efd37cb-5d0d-4080-a20b-65765c2b57b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Hybritech PSA Calibrators
• Version Model Number: 37205
• Catalog Number: 37205
• 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	H628372051 [Primary]

FDA Product Code

• MTF: Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer

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: 2020-02-06
• Device Publish Date: 2014-09-16

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