Accula Flu A / B Test FAB1100CW

GUDID B540FAB1100CW0

The Accula™ Flu A / B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A / B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. Accula Flu A / B assay is intended as an aid in the diagnosis of influenza infections in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

MESA BIOTECH, INC.

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

• Primary Device ID: B540FAB1100CW0
• NIH Device Record Key: 62136306-8d40-491c-a69b-0735e194adac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accula Flu A / B Test
• Version Model Number: FAB1100CW
• Catalog Number: FAB1100CW
• 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: true
• 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: 1-800-965-6288
• Email: techsupport@thermofisher.com
• Phone: 1-800-965-6288
• Email: techsupport@thermofisher.com
• Phone: 1-800-965-6288
• Email: techsupport@thermofisher.com
• Phone: 1-800-965-6288
• Email: techsupport@thermofisher.com
• Phone: 1-800-965-6288
• Email: techsupport@thermofisher.com
• Phone: 1-800-965-6288
• Email: techsupport@thermofisher.com
• Phone: 1-800-965-6288
• Email: techsupport@thermofisher.com
• Phone: 1-800-965-6288
• Email: techsupport@thermofisher.com
• Phone: 1-800-965-6288
• Email: techsupport@thermofisher.com
• Phone: 1-800-965-6288
• Email: techsupport@thermofisher.com
• Phone: 1-800-965-6288
• Email: techsupport@thermofisher.com
• Phone: 1-800-965-6288
• Email: techsupport@thermofisher.com
• Phone: 1-800-965-6288
• Email: techsupport@thermofisher.com
• Phone: 1-800-965-6288
• Email: techsupport@thermofisher.com
• Phone: 1-800-965-6288
• Email: techsupport@thermofisher.com
• Phone: 1-800-965-6288
• Email: techsupport@thermofisher.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
• 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	B540FAB1100CW0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171641

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-25
• Device Publish Date: 2022-10-17

Devices Manufactured by MESA BIOTECH, INC.

• B540FAB1100CW0 - Accula Flu A / B Test: 2022-10-25The Accula™ Flu A / B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A / B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. Accula Flu A / B assay is intended as an aid in the diagnosis of influenza infections in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.
• B540FAB1100CW0 - Accula Flu A / B Test: 2022-10-25 The Accula™ Flu A / B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain rea
• 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