Accula SARS-CoV-2 Test COV4100

GUDID B540COV41000

The Accula™ SARS-Cov-2 Test performed on the Accula™ Dock or the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of the coronavirus SARS-CoV-2 viral RNA. The Accula SARS-CoV-2 Test uses a throat swab and nasal swab specimen collected from patients who meet CDC SARS-CoV-2 clinical criteria and in conjunction with epidemiological criteria to aid in the diagnosis of SARS-CoV-2 infection.

MESA BIOTECH, INC.

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: B540COV41000
• NIH Device Record Key: f0681851-1434-4e82-820a-6d643e6d41e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accula SARS-CoV-2 Test
• Version Model Number: COV4100
• Catalog Number: COV4100
• 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: 858-800-4929
• Email: info@mesabiotech.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B540COV41000 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-21
• Device Publish Date: 2020-04-13

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: 2020-07-07 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: 2020-04-21The Accula™ SARS-Cov-2 Test performed on the Accula™ Dock or the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of the coronavirus SARS-CoV-2 viral RNA. The Accula SARS-CoV-2 Test uses a throat swab and nasal swab specimen collected from patients who meet CDC SARS-CoV-2 clinical criteria and in conjunction with epidemiological criteria to aid in the diagnosis of SARS-CoV-2 infection.
• 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