Silaris Dock

Basic Information

• Brand Name: Silaris Dock
• Primary DI: B54010260
• Version / Model: 1026
• Catalog Number: 1026
• Company Name: MESA BIOTECH, INC.
• Labeler DUNS: 056865474
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-15
• Public Version: 3
• Public Version Date: 2020-07-07
• Public Version Status: Update
• Public Device Record Key: 2f19e5cb-a808-4a67-9513-90b57c78703d

Device Description

The Silaris Dock is an electronic module which executes in vitro diagnostic tests on compatible Silaris 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: Yes
• 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
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay	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 health 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 identified 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	B54010260	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K171641	000