Accula Flu A / B Test

Basic Information

• Brand Name: Accula Flu A / B Test
• Primary DI: B540FAB1100CW0
• Version / Model: FAB1100CW
• Catalog Number: FAB1100CW
• Company Name: MESA BIOTECH, INC.
• Labeler DUNS: 056865474
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-17
• Public Version: 1
• Public Version Date: 2022-10-25
• Public Version Status: New
• Public Device Record Key: 62136306-8d40-491c-a69b-0735e194adac

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	866.3980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47277	Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from influenza A virus and/or influenza B virus in a clinical specimen, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B540FAB1100CW0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K171641	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius