SilarisTM Influenza A&B Starter Pack 1028

GUDID B54010280

The Silaris Starter Pack contains two (2) Silaris Influenza A&B kits and one (1) Silaris Dock for the purposes of starting up a clinical location.

MESA BIOTECH, INC.

Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: B54010280
• NIH Device Record Key: 391adfe8-0d6d-4210-947a-45e8cd05e12d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SilarisTM Influenza A&B Starter Pack
• Version Model Number: 1028
• Catalog Number: 1028
• Company DUNS: 056865474
• Company Name: MESA BIOTECH, INC.
• 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: true
• 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: 781.652.7800
• Email: sdadiagnosticstsdl@sekisuidiag
• Phone: 781.652.7800
• Email: sdadiagnosticstsdl@sekisuidiag
• Phone: 781.652.7800
• Email: sdadiagnosticstsdl@sekisuidiagnostics.com
• Phone: 781.652.7800
• Email: sdadiagnosticstsdl@sekisuidiagnostics.com
• Phone: 781.652.7800
• Email: sdadiagnosticstsdl@sekisuidiagnostics.com
• Phone: 781.652.7800
• Email: sdadiagnosticstsdl@sekisuidiagnostics.com
• Phone: 781.652.7800
• Email: sdadiagnosticstsdl@sekisuidiagnostics.com
• Phone: 781.652.7800
• Email: sdadiagnosticstsdl@sekisuidiagnostics.com
• Phone: 781.652.7800
• Email: sdadiagnosticstsdl@sekisuidiagnostics.com
• Phone: 781.652.7800
• Email: sdadiagnosticstsdl@sekisuidiagnostics.com
• Phone: 781.652.7800
• Email: sdadiagnosticstsdl@sekisuidiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B54010280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171641

FDA Product Code

• OZE: Influenza A And Influenza B Multiplex Nucleic Acid Assay

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-15

Devices Manufactured by MESA BIOTECH, INC.

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• B540FAB1100CWC0 - Accula Flu A / B Control Kit: 2022-10-25 The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in quality control testing with the Accula™ Flu A
• B540D20010 - Accula Programming Cassette: 2020-07-07 The Programming Cassette is an accessory to the Accula Dock and facilitates reprogramming of the Dock’s embedded firmware. Whe
• B540COV41000 - Accula SARS-CoV-2 Test: 2020-04-21 The Accula™ SARS-Cov-2 Test performed on the Accula™ Dock or the Silaris™ Dock is a molecular in vitro diagnostic test uti
• B540D20000 - Accula Dock: 2020-04-21 The Accula Dock is an electronic module which executes in vitro diagnostic tests on compatible Test Cassettes. It consists of an
• B54010400 - Silaris RSV Supplemental Pack: 2020-01-28 The Silaris™ RSV Test performed on the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reac
• B54010240 - Silaris Influenza A&B Control Kit: 2018-07-06 The Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris™
• B54010260 - Silaris Dock: 2018-07-06 The Silaris Dock is an electronic module which executes in vitro diagnostic tests on compatible Silaris Test Cassettes. It consi