AccessGUDID - DEVICE: Accula Dock (B540D20000)

GUDID

Device Identifier (DI) Information

Brand Name: Accula Dock
Version or Model: D2000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D2000
Company Name: MESA BIOTECH, INC.

Primary DI Number: B540D20000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 056865474 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay
OCC	Respiratory Virus Panel Nucleic Acid Assay System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7774b47e-c438-4567-9bf7-aa769e5e7b32
Public Version Date: July 07, 2020
Public Version Number: 2
DI Record Publish Date: April 13, 2020