artus® CMV QS-RGQ MDx Kit 4503346

GUDID 04053228024538

QIAGEN GmbH

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

• Primary Device ID: 04053228024538
• NIH Device Record Key: 314a26a2-2566-43de-ba85-3037bebd1738
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: artus® CMV QS-RGQ MDx Kit
• Version Model Number: 1
• Catalog Number: 4503346
• 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	04053228024538 [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: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-04

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