VIDAS® 30428-01

GUDID 03573026156985

VIDAS® TPSA is a In Vitro Diagnostic kit for the quantitative detection of total prostate specific antigen (PSA) in human serum, using an enzyme immunoassay (EIA) method.

BIOMERIEUX SA

Total prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 03573026156985
• NIH Device Record Key: 4bc87b37-a9db-4eed-a982-b7a49be1f361
• Commercial Distribution Discontinuation: 2017-03-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: VIDAS®
• Version Model Number: TPSA
• Catalog Number: 30428-01
• Company DUNS: 276816717
• Company Name: BIOMERIEUX SA
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026156985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040008

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: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2014-09-23

On-Brand Devices [VIDAS®]

• 03573026156985: VIDAS® TPSA is a In Vitro Diagnostic kit for the quantitative detection of total prostate speci
• 03573026152482: The VIDAS® system is a complete standalone immunodiagnostic system using VIDAS reagents.
• 03573026140427: The VIDAS® system is a complete standalone immunodiagnostic system using VIDAS reagents.