Simplexa™ VZV Positive Control Pack

GUDID 20816101025781

DIASORIN MOLECULAR LLC

Varicella-zoster virus (VZV) nucleic acid IVD, control

• Primary Device ID: 20816101025781
• NIH Device Record Key: 355dff3b-b1b6-4652-bb48-56fa8105c671
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simplexa™ VZV Positive Control Pack
• Version Model Number: MOL3660
• 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

Customer Support Contacts

• Phone: 562-240-6500
• Email: ts.molecular@diasorin.com
• Phone: 562-240-6500
• Email: ts.molecular@diasorin.com
• Phone: 562-240-6500
• Email: ts.molecular@diasorin.com
• Phone: 562-240-6500
• Email: ts.molecular@diasorin.com
• Phone: 562-240-6500
• Email: ts.molecular@diasorin.com
• Phone: 562-240-6500
• Email: ts.molecular@diasorin.com
• Phone: 562-240-6500
• Email: ts.molecular@diasorin.com
• Phone: 562-240-6500
• Email: ts.molecular@diasorin.com
• Phone: 562-240-6500
• Email: ts.molecular@diasorin.com
• Phone: 562-240-6500
• Email: ts.molecular@diasorin.com
• Phone: 562-240-6500
• Email: ts.molecular@diasorin.com
• Phone: 562-240-6500
• Email: ts.molecular@diasorin.com
• Phone: 562-240-6500
• Email: ts.molecular@diasorin.com
• Phone: 562-240-6500
• Email: ts.molecular@diasorin.com
• Phone: 562-240-6500
• Email: ts.molecular@diasorin.com
• Phone: 562-240-6500
• Email: ts.molecular@diasorin.com
• Phone: 562-240-6500
• Email: ts.molecular@diasorin.com
• Phone: 562-240-6500
• Email: ts.molecular@diasorin.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	20816101025781 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190219

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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• 10816101027221 - Prothrombin (FII) HyBeacon Gen II Primer Pair: 2024-10-02
• 10816101027283 - Monkeypox Primer Pair: 2024-08-30
• 10816101027290 - Human GAPDH Endogenous Primer Pair: 2024-08-30
• 20816101027198 - Simplexa™ C. auris Direct: 2024-07-29