Simplexa™ Flu A/B & RSV Positive Control Pack

GUDID 20816101025552

DIASORIN MOLECULAR LLC

Multiple respiratory virus nucleic acid IVD, control

• Primary Device ID: 20816101025552
• NIH Device Record Key: b3827367-e6ad-4622-812b-914c7f26e90f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simplexa™ Flu A/B & RSV Positive Control Pack
• Version Model Number: MOL2660
• 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: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.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
• 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	20816101025552 [Primary]

FDA Product Code

• OCC: Respiratory Virus Panel Nucleic Acid Assay 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-22

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• 20816101027211 - Simplexa™ C. auris Positive Control Pack: 2024-07-29
• 20816101027235 - Simplexa™ C. auris Sample Prep Kit: 2024-07-29
• 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