Access Hybritech free PSA QC 37219

GUDID H628372191

The Access Hybritech free PSA QC are bi-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of free Prostate Specific Antigen (free PSA) using the Access Immunoassay Systems.

Beckman Coulter, Inc.

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

• Primary Device ID: H628372191
• NIH Device Record Key: f953cdb7-ba71-4c30-bd0e-eda0d7666332
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Hybritech free PSA QC
• Version Model Number: 37219
• Catalog Number: 37219
• 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	H628372191 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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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