Simplexa COVID-19 & Flu A/B Positive Control Pack MOL4260

GUDID 20816101027150

DIASORIN MOLECULAR LLC

Multiple respiratory virus nucleic acid IVD, control

• Primary Device ID: 20816101027150
• NIH Device Record Key: 128824f1-926b-4bf3-ad11-33ec7ee0cdea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simplexa COVID-19 & Flu A/B Positive Control Pack
• Version Model Number: MOL4260
• Catalog Number: MOL4260
• 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: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• Email: TS.molecular@diasorin.com
• Phone: 562-2406500
• 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
• 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	20816101027150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220963

FDA Product Code

• QOF: Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

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: 2023-06-26
• Device Publish Date: 2023-06-16

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• 10816101022240 - DxSelect™ Amber Sample Diluent: 2024-07-09
• 10816101022325 - West Nile Virus IgG DxSelect™ IgG Cutoff Calibrator: 2024-07-08
• 10816101022332 - West Nile Virus IgG Positive Control DxSelect™ - IgG Positive Control: 2024-07-08
• 10816101022349 - West Nile Virus IgG DxSelect™ - IgG Antigen Wells: 2024-07-08
• 10816101022356 - DxSelect™ - 10X Wash Buffer: 2024-07-08