Device
The Myrna instrument is an automated in vitro diagnostic (IVD) device intended for use with FDA cleared or approved Inflammatix cartridges only. The Myrna instrument is intended to...
Manufacturer
Inflammatix, Inc.
Inflammatix, Inc.
Model: MYRNA-1000
Catalog: MYRNA-1000
DI: 00850028489017
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
The Myrna instrument is an automated in vitro diagnostic (IVD) device intended for use with FDA cleared or approved Inflammatix cartridges only. The Myrna instrument is intended to be used by healthcare professionals, and exclusively with Inflammatix test cartridges.
The Myrna instrument is a platform instrument that provides pneumatic, thermal, motor, and optical control to complete the steps in an assay and runs a classifier to process the data acquired and produce the test results. An included touch screen display provides the primary method of input and, in concert with a graphical user interface, guides the user through the steps necessary to initiate a run. An outward facing barcode scanner acts as the primary method for entering information into the instrument software during a normal test workflow.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
23f54c09-50a9-49cb-a838-6d8f29d7a78d
Distribution Status:
In Commercial Distribution
DUNS Number:
080387361
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850028489017
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 62730
Name: Isothermal nucleic acid amplification analyser IVD, point-of-care
Definition:
A portable, electrically-powered instrument intended to be used by health professionals at the point-of-care for the amplification of target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen. It amplifies the target nucleic acids at a constant (isothermal) temperature, using a series of transcription and reverse transcription reactions, and detects and/or identifies the amplified product using oligonucleotide markers as it is produced (e.g., in real-time).
FDA Product Codes
OOI
Real Time Nucleic Acid Amplification System
Premarket Submissions
Submission Number:
K241676
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
15
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
30
Item #1 - Storage Handling Type:
Handling Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
20
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
80
Item #2 - Storage Handling Type:
Handling Environment Humidity
Item #3 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #3 - Storage Handling Low - @attributes - Value:
76.1
Item #3 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #3 - Storage Handling High - @attributes - Value:
101.3
Item #3 - Storage Handling Type:
Handling Environment Atmospheric Pressure