CEDIA Cyclosporine-PLUS Assay

GUDID 00884883011861

Microgenics Corporation

Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, fluorescent immunoassay

• Primary Device ID: 00884883011861
• NIH Device Record Key: a7657009-1dd8-405c-abe4-fe7e443d1fa2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEDIA Cyclosporine-PLUS Assay
• Version Model Number: 10016283
• Company DUNS: 122153799
• Company Name: Microgenics Corporation
• 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: false
• Device Combination Product: false
• Single Use: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884883011861 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023208

FDA Product Code

• JIS: Calibrator, Primary
• MKW: Cyclosporine

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: 2019-04-30
• Device Publish Date: 2016-09-24

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