Light Diagnostics VZV DFA Reagent 5094

GUDID 04053252732638

VZV DFA Reagent

EMD Millipore Corporation

Varicella-zoster virus (VZV) antigen IVD, kit, fluorescent immunoassay

• Primary Device ID: 04053252732638
• NIH Device Record Key: 2c4b1bb1-9718-437b-9219-a8f784929c68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Light Diagnostics VZV DFA Reagent
• Version Model Number: 5094
• Catalog Number: 5094
• Company DUNS: 829517072
• Company Name: EMD Millipore 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: 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053252732638 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951799

FDA Product Code

• GQX: Antiserum, Cf, Varicella-Zoster

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: 2020-04-13
• Device Publish Date: 2020-04-03

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