artus® CMV RGQ MDx Kit 4503245

GUDID 04053228002086

QIAGEN GmbH

Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 04053228002086
• NIH Device Record Key: 200eee08-c7a9-4a21-a8e7-e0cb2c8ea93f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: artus® CMV RGQ MDx Kit
• Version Model Number: 1
• Catalog Number: 4503245
• Company DUNS: 317103745
• Company Name: QIAGEN GmbH
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053228002086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130027

FDA Product Code

• PAB: Cytomegalovirus (Cmv) Dna Quantitative Assay

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-04

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