FDA.reportPublic FDA data

Myrna

Primary DI
00850028489017
Brand
Myrna
Company
Inflammatix, Inc.
Model
MYRNA-1000
Catalog number
MYRNA-1000
Device 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.
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOIReal Time Nucleic Acid Amplification System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241676000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241676000TriVerityInflammatix, Inc.2025-01-10PRE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850028489017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850028489017008500284890178500284890170850028489017

GMDN Terms#

Term, Definition table
TermDefinition
Isothermal nucleic acid amplification analyser IVD, point-of-careA 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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure76.1 KiloPascal101.3 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
18666946359support@inflammatix.com

Regulatory Flags#

DUNS number
080387361
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850028489024TriVerityTRIVERITY-2000TRIVERITY-20002026-04-30
00850028489048TriVerity Level 1 Quality ControlLEVEL 1 QUALITY CONTROL2026-04-30
00850028489055TriVerity Level 2 Quality ControlLEVEL 2 QUALITY CONTROL2026-04-30
00850028489093TriVerity Verification PanelTRIVERITY-4000TRIVERITY-40002026-04-30
00850028489109TriVerity Mini Verification PanelTRIVERITY-5000TRIVERITY-50002026-04-30

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