Access Hybritech PSA 37200

GUDID H628372001

The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems. This device is indicated for the measurement of serum PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. This device is further indicated for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer.

Beckman Coulter, Inc.

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

• Primary Device ID: H628372001
• NIH Device Record Key: 682ca75e-5b02-4d6f-9c78-92743e875e37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Hybritech PSA
• Version Model Number: 37200
• Catalog Number: 37200
• 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	H628372001 [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

On-Brand Devices [Access Hybritech PSA]

• H628372001: The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the
• 15099590701673: The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the