Accula Dock

Basic Information

• Brand Name: Accula Dock
• Primary DI: B540D20000
• Version / Model: D2000
• Catalog Number: D2000
• Company Name: MESA BIOTECH, INC.
• Labeler DUNS: 056865474
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-13
• Public Version: 3
• Public Version Date: 2025-07-14
• Public Version Status: Update
• Public Device Record Key: 7774b47e-c438-4567-9bf7-aa769e5e7b32

Device Description

The Accula Dock is an electronic module which executes in vitro diagnostic tests on compatible Test Cassettes. It consists of an electro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary to orchestrate in-vitro diagnostic tests within the inserted Test Cassette.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown		N
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay	Microbiology	866.3980	2
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	866.3980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62875	Thermal cycler nucleic acid amplification analyser IVD, point-of-care	A portable, electrically-powered instrument intended to be used by healthcare professionals at the point-of-care to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or quantified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B540D20000	HIBCC

Customer Contacts

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

Storage Conditions

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