ARIES® Bordetella Assay

GUDID 00840487101452

The ARIES® Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis.

LUMINEX CORPORATION

Multiple Bordetella species nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00840487101452
• NIH Device Record Key: 7098f863-67e0-47cf-ac4f-7110f6e84bfc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARIES® Bordetella Assay
• Version Model Number: 50-10037
• Company DUNS: 965476641
• Company Name: LUMINEX 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(512)381-4397
• Email: support@luminexcorp.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840487101452 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163626

FDA Product Code

• OZZ: Bordetella pertussis dna assay system

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: 2017-05-09

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