Universal Disc Cover Tape

GUDID 10816101025111

DIASORIN MOLECULAR LLC

Assay adhesive sealing/fixation film IVD Assay adhesive sealing/fixation film IVD Assay adhesive sealing/fixation film IVD Assay adhesive sealing/fixation film IVD Assay adhesive sealing/fixation film IVD Assay adhesive sealing/fixation film IVD Assay adhesive sealing/fixation film IVD Assay adhesive sealing/fixation film IVD Assay adhesive sealing/fixation film IVD Assay adhesive sealing/fixation film IVD Assay adhesive sealing/fixation film IVD Assay adhesive sealing/fixation film IVD Assay adhesive sealing/fixation film IVD Assay adhesive sealing/fixation film IVD Assay adhesive sealing/fixation film IVD Assay adhesive sealing/fixation film IVD Assay adhesive sealing/fixation film IVD

• Primary Device ID: 10816101025111
• NIH Device Record Key: 31b1eeff-1812-478c-ab6c-f09ef6641639
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal Disc Cover Tape
• Version Model Number: MOL1500
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10816101025111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102314

FDA Product Code

• OOI: Real Time Nucleic Acid Amplification 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: 4
• Public Version Date: 2021-12-08
• Device Publish Date: 2017-07-11

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• 20816101027037 - Simplexa COVID-19 Positive Control Pack: 2023-06-26
• 20816101027150 - Simplexa COVID-19 & Flu A/B Positive Control Pack: 2023-06-26
• 10816101022295 - DxSelect™ - Substrate Reagent: 2023-06-02
• 10816101025111 - Universal Disc Cover Tape: 2021-12-08
• 10816101025111 - Universal Disc Cover Tape: 2021-12-08