Simplexa™ Bordetella Positive Control Pack MOL2760

GUDID 20816101025637

Simplexa™ Bordetella Positive Control Pack

DIASORIN MOLECULAR LLC

Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 20816101025637
• NIH Device Record Key: 0c310ea7-295f-4332-be2d-beeaeb9ce9a2
• Commercial Distribution Discontinuation: 2018-08-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Simplexa™ Bordetella Positive Control Pack
• Version Model Number: MOL2760
• Catalog Number: MOL2760
• 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800)838-4548
• Email: technicalinfo.molecular@diasor
• Phone: (800)838-4548
• Email: technicalinfo.molecular@diasor
• Phone: (800)838-4548
• Email: technicalinfo.molecular@diasorin.com
• Phone: (800)838-4548
• Email: technicalinfo.molecular@diasorin.com
• Phone: (800)838-4548
• Email: technicalinfo.molecular@diasorin.com
• Phone: (800)838-4548
• Email: technicalinfo.molecular@diasorin.com
• Phone: (800)838-4548
• Email: technicalinfo.molecular@diasorin.com
• Phone: (800)838-4548
• Email: technicalinfo.molecular@diasorin.com
• Phone: (800)838-4548
• Email: technicalinfo.molecular@diasorin.com
• Phone: (800)838-4548
• Email: technicalinfo.molecular@diasorin.com
• Phone: (800)838-4548
• Email: technicalinfo.molecular@diasorin.com
• Phone: (800)838-4548
• Email: technicalinfo.molecular@diasorin.com
• Phone: (800)838-4548
• Email: technicalinfo.molecular@diasorin.com
• Phone: (800)838-4548
• Email: technicalinfo.molecular@diasorin.com
• Phone: (800)838-4548
• Email: technicalinfo.molecular@diasorin.com
• Phone: (800)838-4548
• Email: technicalinfo.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	20816101025637 [Primary]

FDA Product Code

• OZZ: Bordetella Pertussis Dna Assay 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: 2018-09-24
• Device Publish Date: 2018-08-24

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