Accula Programming Cassette D2001

GUDID B540D20010

The Programming Cassette is an accessory to the Accula Dock and facilitates reprogramming of the Dock’s embedded firmware. When firmware updates are needed, the firmware will be stored onto Programming Cassettes and sent to end users, who will load the Programming Cassette into their Dock and re-program its firmware

MESA BIOTECH, INC.

Thermal cycler nucleic acid amplification analyser IVD, point-of-care Thermal cycler nucleic acid amplification analyser IVD, point-of-care Thermal cycler nucleic acid amplification analyser IVD, point-of-care Thermal cycler nucleic acid amplification analyser IVD, point-of-care Thermal cycler nucleic acid amplification analyser IVD, point-of-care Thermal cycler nucleic acid amplification analyser IVD, point-of-care Thermal cycler nucleic acid amplification analyser IVD, point-of-care Thermal cycler nucleic acid amplification analyser IVD, point-of-care Thermal cycler nucleic acid amplification analyser IVD, point-of-care

• Primary Device ID: B540D20010
• NIH Device Record Key: ec9b032d-3f1f-458d-ac69-602c3e6d9ccb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accula Programming Cassette
• Version Model Number: D2001
• Catalog Number: D2001
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 858-800-4929
• Email: info@mesabiotech.com
• Phone: 858-800-4929
• Email: info@mesabiotech.com
• Phone: 858-800-4929
• Email: info@mesabiotech.com
• Phone: 858-800-4929
• Email: info@mesabiotech.com
• Phone: 858-800-4929
• Email: info@mesabiotech.com
• Phone: 858-800-4929
• Email: info@mesabiotech.com
• Phone: 858-800-4929
• Email: info@mesabiotech.com
• Phone: 858-800-4929
• Email: info@mesabiotech.com
• Phone: 858-800-4929
• Email: info@mesabiotech.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B540D20010 [Primary]

FDA Product Code

• QJR: Reagents, 2019-Novel Coronavirus Nucleic Acid

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: 2020-07-07
• Device Publish Date: 2020-06-08

Devices Manufactured by MESA BIOTECH, INC.

• 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: 2020-07-07The Programming Cassette is an accessory to the Accula Dock and facilitates reprogramming of the Dock’s embedded firmware. When firmware updates are needed, the firmware will be stored onto Programming Cassettes and sent to end users, who will load the Programming Cassette into their Dock and re-program its firmware
• 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