Simplexa™ VZV Direct

GUDID 20816101025774

DIASORIN MOLECULAR LLC

Varicella-zoster virus (VZV) nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 20816101025774
• NIH Device Record Key: d213d7b0-4aff-4371-94c0-249f38e04fd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simplexa™ VZV Direct
• Version Model Number: MOL3650
• Company DUNS: 080271715
• Company Name: DIASORIN MOLECULAR LLC
• 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	20816101025774 [Primary]

FDA Product Code

• PLO: Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System

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: 2019-06-27
• Device Publish Date: 2019-06-19

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