VIDAS® FSH

GUDID 03573026156947

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

BIOMERIEUX SA

Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 03573026156947
• NIH Device Record Key: 24fcfc12-95ed-481f-a1d8-fa4a7d4cd627
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIDAS® FSH
• Version Model Number: 30407-01
• 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	03573026156947 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921746

FDA Product Code

• CGJ: RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE

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: 2019-10-03
• Device Publish Date: 2019-09-25

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