VIDAS® Prolactin

GUDID 03573026156961

VIDAS ® Prolactin (PRL) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the detection of prolactin concentration in human serum or plasma .

BIOMERIEUX SA

Prolactin IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 03573026156961
• NIH Device Record Key: 2cd58615-5896-409c-8909-b171ed932df6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIDAS® Prolactin
• Version Model Number: 30410-01
• 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	03573026156961 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943811

FDA Product Code

• CFT: RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-27
• Device Publish Date: 2019-11-19

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